Data / Drug companies / Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC: 273 products in the FDA NDC directory, labeler code 65162
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Amneal Pharmaceuticals LLC (labeler code 65162) lists 273 products in the FDA National Drug Code Directory, covering 115 finished drugs by generic name. By type: 260 prescription drugs, 13 over the counter drugs. Its main marketing category is generic drugs (ANDA). The newest product started marketing on September 12, 2025.
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- Labeler code
- 65162
- Products in commercial distribution
- 273
- Packages
- 714
- Finished drugs by generic name
- 115
- Prescription products
- 260
- Over the counter products
- 13
- Controlled substance products
- Schedule II 13, Schedule III 4, Schedule IV 10, Schedule V 1
- Flagged as original packager
- 251 of 251 products that carry the flag
- Started marketing in the last 12 months
- 0
- Products with a marketing end date set
- 1
- Earliest marketing start
- November 25, 1998
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 269 | 98.5% |
| Other unapproved drugs | 4 | 1.5% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 260 | 95.2% |
| Over the counter drugs | 13 | 4.8% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 100 | 36.6% |
| Capsule | 36 | 13.2% |
| Tablet, film coated | 30 | 11% |
| Tablet, extended release | 23 | 8.4% |
| Solution | 16 | 5.9% |
| Patch, extended release | 10 | 3.7% |
| Suspension | 7 | 2.6% |
| Tablet, film coated, extended release | 7 | 2.6% |
| Tablet, delayed release | 6 | 2.2% |
| Tablet, coated | 6 | 2.2% |
| Patch | 5 | 1.8% |
| Capsule, extended release | 5 | 1.8% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Sodium Oxybate | 65162-065 | Solution | Generic drugs (ANDA) | September 12, 2025 |
| Mesalamine | 65162-360 | Tablet, delayed release | Generic drugs (ANDA) | February 19, 2025 |
| Pitavastatin | 65162-031 | Tablet, film coated | Generic drugs (ANDA) | August 21, 2024 |
| Pitavastatin | 65162-030 | Tablet, film coated | Generic drugs (ANDA) | August 21, 2024 |
| Pitavastatin | 65162-029 | Tablet, film coated | Generic drugs (ANDA) | August 21, 2024 |
| Dapsone | 65162-339 | Gel | Generic drugs (ANDA) | October 24, 2023 |
| Lisdexamfetamine Dimesylate | 65162-028 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Lisdexamfetamine Dimesylate | 65162-027 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Lisdexamfetamine Dimesylate | 65162-026 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Lisdexamfetamine Dimesylate | 65162-025 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Lisdexamfetamine Dimesylate | 65162-024 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Lisdexamfetamine Dimesylate | 65162-023 | Capsule | Generic drugs (ANDA) | August 28, 2023 |
| Valsartan and Hydrochlorothiazide | 65162-849 | Tablet, film coated | Generic drugs (ANDA) | August 14, 2023 |
| Valsartan and Hydrochlorothiazide | 65162-848 | Tablet, film coated | Generic drugs (ANDA) | August 14, 2023 |
| Valsartan and Hydrochlorothiazide | 65162-847 | Tablet, film coated | Generic drugs (ANDA) | August 14, 2023 |
| Valsartan and Hydrochlorothiazide | 65162-846 | Tablet, film coated | Generic drugs (ANDA) | August 14, 2023 |
| Valsartan and Hydrochlorothiazide | 65162-845 | Tablet, film coated | Generic drugs (ANDA) | August 14, 2023 |
| Fesoterodine Fumarate | 65162-370 | Tablet, extended release | Generic drugs (ANDA) | January 6, 2023 |
| Fesoterodine Fumarate | 65162-369 | Tablet, extended release | Generic drugs (ANDA) | January 6, 2023 |
| Lurasidone Hydrochloride | 65162-882 | Tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Lurasidone Hydrochloride | 65162-881 | Tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Lurasidone Hydrochloride | 65162-880 | Tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Lurasidone Hydrochloride | 65162-879 | Tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Lurasidone Hydrochloride | 65162-082 | Tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Diclofenac Sodium | 65162-683 | Solution | Generic drugs (ANDA) | August 23, 2022 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.