FDA NDC Directory
Recently listed NDCs
Finished products in the FDA NDC Directory with the newest marketing start dates — new brands and generics, and new strengths or packages of existing products.
A listing is not an approval
The date shown is the marketing start date the labeler reported. Many new listings are generics, repackaged or relabeled products, or new package sizes. The marketing category (NDA, ANDA, BLA) on each product page says under what authority it is marketed.
Newest first
831 listings in the last 90 days
| Product | Strength | Form · route | Labeler | Listed | Product NDC |
|---|---|---|---|---|---|
| Tolvaptan | — | KitOral | Apotex Corp. | Aug 6, 2026 | 60505-4801 |
| Tolvaptan | — | KitOral | Apotex Corp. | Aug 6, 2026 | 60505-4802 |
| Tolvaptan | — | KitOral | Apotex Corp. | Aug 6, 2026 | 60505-4803 |
| Tolvaptan | — | KitOral | Apotex Corp. | Aug 6, 2026 | 60505-4804 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | Aug 6, 2026 | 60760-967 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | REMEDYREPACK INC. | Aug 6, 2026 | 70518-4722 |
| Mycophenolate Mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | QUAGEN PHARMACEUTICALS LLC | Aug 6, 2026 | 70752-294 |
| Niacin | Niacin 500 mg/1 | Tablet, Extended releaseOral | QUAGEN PHARMACEUTICALS LLC | Aug 6, 2026 | 70752-295 |
| Niacin | Niacin 1000 mg/1 | Tablet, Extended releaseOral | QUAGEN PHARMACEUTICALS LLC | Aug 6, 2026 | 70752-296 |
| Salicortriethanolamine salicylate | Tea-salicylate 40.2 mg/1 | PatchTransdermal | Advanced Rx of Tennessee, LLC | Aug 6, 2026 | 80425-0592 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | Aug 6, 2026 | 87564-013 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | Aug 6, 2026 | 87564-014 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | Aug 6, 2026 | 87564-015 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | Aug 6, 2026 | 87564-016 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | Aug 6, 2026 | 87564-017 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amerisyn LLC | Aug 6, 2026 | 87564-051 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Amerisyn LLC | Aug 6, 2026 | 87564-052 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Amerisyn LLC | Aug 6, 2026 | 87564-053 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Amerisyn LLC | Aug 6, 2026 | 87564-054 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Aurobindo Pharma Limited | Aug 5, 2026 | 59651-533 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Aurobindo Pharma Limited | Aug 5, 2026 | 59651-534 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Aurobindo Pharma Limited | Aug 5, 2026 | 59651-535 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Aurobindo Pharma Limited | Aug 5, 2026 | 59651-536 |
| sugammadex | Sugammadex sodium 200 mg/2mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | Aug 4, 2026 | 16729-726 |
| sugammadex | Sugammadex sodium 500 mg/5mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | Aug 4, 2026 | 16729-727 |