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
219 listings in the last 30 days
| Product | Strength | Form · route | Labeler | Listed | Product NDC |
|---|---|---|---|---|---|
| Utebzitebipenem pivoxil | Tebipenem pivoxil hydrobromide 300 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | Oct 1, 2026 | 0173-0956 |
| Lactated Ringerssodium chloride, sodium lactate, potassium chloride, and calcium chloride | Sodium chloride .6 g/100mL + 3 more ingredients | Injection, SolutionIntravenous | B. Braun Medical Inc. | Oct 1, 2026 | 0264-7500 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | Oct 1, 2026 | 0781-2731 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | Oct 1, 2026 | 0781-2732 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | Oct 1, 2026 | 0781-2733 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | Oct 1, 2026 | 0781-2734 |
| Claforancefotaxime | Cefotaxime sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | SteriMax Inc. | Oct 1, 2026 | 21586-031 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Oct 1, 2026 | 27808-325 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Oct 1, 2026 | 27808-326 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Oct 1, 2026 | 27808-327 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Oct 1, 2026 | 27808-328 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Oct 1, 2026 | 27808-329 |
| Trentalpentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Validus Pharmaceuticals LLC | Oct 1, 2026 | 30698-006 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | TabletOral | Micro Labs Limited | Oct 1, 2026 | 42571-317 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | TabletOral | Micro Labs Limited | Oct 1, 2026 | 42571-318 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Micro Labs Limited | Oct 1, 2026 | 42571-320 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Micro Labs Limited | Oct 1, 2026 | 42571-321 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Micro Labs Limited | Oct 1, 2026 | 42571-322 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Micro Labs Limited | Oct 1, 2026 | 42571-323 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | Apotex Corp | Oct 1, 2026 | 60505-4956 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .1 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | Oct 1, 2026 | 65219-296 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .2 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | Oct 1, 2026 | 65219-298 |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | TabletOral | Lifestar Pharma LLC | Oct 1, 2026 | 70756-006 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Lifestar Pharma LLC | Oct 1, 2026 | 70756-684 |
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Zydus Lifesciences Limited | Oct 1, 2026 | 70771-1933 |