Several identifiable companies appear in FDA and DailyMed records for sildenafil ED tablets, but “manufacturer” can mean a legal application holder, an actual finished-dose manufacturing facility, a labeler or a distributor. Teva Pharmaceuticals USA and Aurobindo Pharma are two independently documented U.S.-approved generic ED-tablet examples; the regulatory records must be read at product level rather than used as a popularity ranking or a live inventory list.
For U.S. ED products, the useful starting point is the exact sildenafil strength, film-coated oral tablet, approved application and corresponding labeling. FDA Orange Book records establish approval and therapeutic-equivalence information where applicable, while the NDC Directory and DailyMed identify listed packages and labelers. A company association or NDC alone does not prove that a specific seller has a genuine product or that a pharmacy can fill the prescription today.
This guide includes named product-record examples and a method for interpreting them, not an unsourced claim about the best or cheapest maker. Generic sildenafil explains approval and equivalence as a product category; the Indian brands directory covers separate foreign-market identities, not U.S. dispensing approval.
The firm holding an approved NDA or ANDA is legally associated with that application, while another facility may manufacture the finished tablets under contract. A listed labeler can be the organization distributing the product under its name. Repackagers and relabelers may appear on drug-package records without being the original finished-dose manufacturer.
When a pharmacy label names a company, the safest interpretation is “the named role shown on this specific record,” not a blanket statement that the firm invented, manufactured and distributes every sildenafil product. Compare the labeler, application holder and actual manufacturing statements separately.
The Orange Book contains FDA-approved drug products and related application identifiers, including the dosage form, route, strength, applicant and where applicable therapeutic-equivalence evaluation. These fields help distinguish a specific generic sildenafil ED tablet from a product sharing only the sildenafil ingredient name.
Approval status can be checked against the exact application and product record. It does not establish real-time pharmacy inventory, whether a particular company’s tablet is on a store shelf or the final prescription cost. The pharmacy availability guide handles the separate stock-check task.
An NDC is an identifier for a listed drug product and package. FDA explicitly distinguishes a listing from an agency determination that the product is approved. Companies submit listing details, and the listed name may be a labeler or other entity rather than the person who physically manufactured the tablets.
A matching NDC can be useful when a pharmacist identifies a dispensed package, but approval should be cross-checked against the applicable NDA or ANDA and official product labeling. The comparison below helps avoid relying on a single identifier.
| Record or field | Can help establish | Cannot establish alone |
|---|---|---|
| Orange Book approval/application | FDA-approved product and application context | Real-time stock or retail price |
| NDC and labeler | Listed product or package identity | FDA approval of that product |
| Manufacturer printed on packaging | Claimed or recorded supply-chain role | Approval for every product the company sells |
| Pharmacy dispensing label | What the patient was dispensed | Accuracy of an unrelated online product offer |
Viagra is an FDA-approved brand-name sildenafil ED tablet, while multiple approved generics have their own applications, labelers and supply-chain arrangements. The specific Teva and Aurobindo records below demonstrate these differences without implying that either company’s inventory is available nationwide.
Do not assume every sildenafil supplier represents a separate active ingredient or therapeutic advantage. The Viagra brand guide covers the brand identity, generic sildenafil covers the generic category, and their comparison explains substitution questions.
Concrete U.S. records answer the manufacturer question better than a generic directory. FDA lists Teva Pharmaceuticals USA as an applicant for sildenafil citrate ED tablets under ANDA 077342, with 25 mg, 50 mg and 100 mg approved tablet products; its DailyMed labels identify Teva as the labeler. Aurobindo Pharma Limited appears in DailyMed with an ED tablet label tied to ANDA 203962 for the same three strengths. The Aurobindo listing also identifies a manufacturing establishment for those product codes.
The third example demonstrates a different role: Greenstone LLC appears on a sildenafil citrate label as a distributor. A distributor name on a package should not automatically be interpreted as the physical factory or the original generic applicant. These records illustrate manufacturer, application and distribution distinctions; their existence is not a real-time assertion that particular packages remain in stock at a patient’s pharmacy.
| Company / named role | Documented product or application | What can safely be concluded |
|---|---|---|
| Teva Pharmaceuticals USA — FDA generic applicant / labeler | ANDA 077342; sildenafil ED tablets 25, 50 and 100 mg | Named U.S.-approved ED generic application; confirm actual dispensed product |
| Aurobindo Pharma Limited — labeler and listed manufacturing establishment | ANDA 203962; sildenafil oral ED tablets 25, 50 and 100 mg | DailyMed identifies application and a manufacturing role for its listed product codes |
| Greenstone LLC — listed distributor | Sildenafil citrate ED tablet labels show “Distributed by Greenstone LLC” | A distribution role is not, by itself, evidence of physical manufacture |
The U.S. Viagra ED tablet label includes 25 mg, 50 mg and 100 mg strengths. Product names and catalog records for sildenafil used in pulmonary arterial hypertension may show other strengths, forms or schedules, so a broad search for “sildenafil manufacturers” can blend clinically distinct product lines.
A meaningful manufacturer record should match the ED oral-tablet indication and precise marketed presentation. The sildenafil strengths guide organizes ED tablets without treating PAH presentations as interchangeable.
An FDA-approved generic is evaluated against the relevant reference product under applicable requirements for active ingredient, quality, dosage form, strength and bioequivalence. That framework provides more useful assurance than a claim that a manufacturer is large, popular, “WHO-grade” or active in numerous export markets.
Differences in tablet appearance or inactive ingredients may exist across approved generics. The pharmacist can confirm whether substitution is permitted under the prescription and state rules, and help identify the actual product supplied.
A refill might be supplied from another approved manufacturer or listed labeler, subject to pharmacy inventory, applicable substitution rules and the prescription. The resulting tablet may have a different imprint, color or package without necessarily indicating that the active ingredient changed.
If the product appearance differs unexpectedly, the patient should consult the pharmacist before using it rather than relying on a photograph found online. A different firm name is a reason to verify the record, not automatically proof of counterfeit medicine.
Some Indian pharmaceutical companies manufacture or market products in several countries, including in some cases U.S.-approved medicines. That does not mean every India-market product sold under the same company name is an FDA-approved product. Approval attaches to the particular application, formulation and labeled presentation.
The Indian sildenafil brands directory organizes country-specific product identity, company claims and combinations. Those foreign brand pages must not be used to imply U.S. approval or lawful cross-border retail supply.
Ask the licensed pharmacy to confirm the active ingredient, strength, oral dosage form, labeled product name and manufacturer or labeler on the dispensed package. When the supplier changes, ask whether the pharmacy is dispensing an approved generic permitted by the prescription.
If a product’s imprint, labeling or claimed approval cannot be reconciled, contact the pharmacy before use. The local pharmacy guide explains practical pickup verification, and the online pharmacy guide addresses remote dispensing credentials.
Teva and Aurobindo are verifiable examples of generic sildenafil ED product records, not finalists in a “best manufacturer” ranking. FDA approval, therapeutic equivalence, current pharmacy availability, physical manufacture and suitability for an individual prescription are separate determinations. Rankings based on retail listings or brand familiarity cannot establish all five.
A more useful decision process starts with the approved product and prescription and then asks which manufacturer or labeler supplied the actual fill. The sildenafil overview remains the main hub for medical and product decisions; this page remains a record-verification guide.
Examples documented in U.S. FDA/DailyMed records include Teva Pharmaceuticals USA (ANDA 077342) and Aurobindo Pharma Limited (ANDA 203962) for sildenafil ED tablets. Check the exact application, labeler and dispensed product; this is not a complete list or an inventory guarantee.
Not necessarily. It may be the labeler, distributor or repackager; company roles should be checked separately.
No. An NDC is a listing identifier and does not itself indicate that FDA approved the product.
It identifies approved drug products and includes applicant, formulation, strength and relevant therapeutic-equivalence records.
Yes. Approved generics from different suppliers can have different appearance or inactive ingredients. Ask the pharmacist to confirm the change.
They can overlap by ingredient but involve distinct product indications, strengths or forms that must not be assumed interchangeable.
No. FDA approval must be verified for the exact marketed product, not inferred from a company’s international operations.
No. Product approval and pharmacy inventory are separate issues.