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 |
|---|---|---|---|---|---|
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | Sep 1, 2026 | 59746-434 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | Sep 1, 2026 | 59746-435 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | Sep 1, 2026 | 59746-436 |
| Propranolol Hydrochloride | Propranolol hydrochloride 40 mg/1 | TabletOral | American Health Packaging | Sep 1, 2026 | 60687-948 |
| tramadol hydrochloride | Tramadol hydrochloride 25 mg/1 | TabletOral | Strides Pharma Science Limited | Sep 1, 2026 | 64380-778 |
| Mycophenolate Mofetil | Mycophenolate mofetil 200 mg/mL | Powder, For suspensionOral | Strides Pharma Science Limited | Sep 1, 2026 | 64380-899 |
| Tolvaptan | Tolvaptan 15 mg/1 | TabletOral | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-915 |
| Tolvaptan | Tolvaptan 30 mg/1 | TabletOral | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-916 |
| Tolvaptan | Tolvaptan 45 mg/1 | TabletOral | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-917 |
| Tolvaptan | Tolvaptan 60 mg/1 | TabletOral | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-918 |
| Tolvaptan | Tolvaptan 90 mg/1 | TabletOral | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-919 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-920 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-921 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-922 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-923 |
| Tolvaptan | — | Kit | Ascend Laboratories, LLC | Sep 1, 2026 | 67877-924 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | Sep 1, 2026 | 70518-4742 |
| Acetazolamideacetazolamide sodium | Acetazolamide sodium 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | Sep 1, 2026 | 72078-092 |
| Clofarabine | Clofarabine 1 mg/mL | InjectionIntravenous | Novadoz Pharmaceuticals LLC | Sep 1, 2026 | 72205-394 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | NorthStar Rx LLC | Sep 1, 2026 | 72603-817 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | Sep 1, 2026 | 81469-168 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | Sep 1, 2026 | 81469-169 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | Sep 1, 2026 | 84386-023 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aurobindo Pharma Limited | Sep 1, 2026 | 84386-024 |
| Mesalamine | Mesalamine 4 g/60mL | SuspensionRectal | KLM Laboratories Private Limited | Sep 1, 2026 | 84725-002 |