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
470 listings in the last 30 days
| Product | Strength | Form · route | Labeler | Type | Listed | Product NDC |
|---|---|---|---|---|---|---|
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Encube Ethicals, Inc. | Prescription drug | Oct 1, 2026 | 21922-110 |
| terrasil Foreskin Reliefallantoin | Allantoin .5 g/100g | OintmentTopical | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | Over-the-counter drug | Oct 1, 2026 | 24909-058 |
| terrasil Foreskin Relief Kitallantoin | — | KitTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | Over-the-counter drug | Oct 1, 2026 | 24909-068 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-322 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-323 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-324 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-325 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-326 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-327 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-328 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | Prescription drug | Oct 1, 2026 | 27808-329 |
| Trentalpentoxifylline | Pentoxifylline 400 mg/1 | Tablet, Extended releaseOral | Validus Pharmaceuticals LLC | Prescription drug | Oct 1, 2026 | 30698-006 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | TabletOral | Micro Labs Limited | Prescription drug | Oct 1, 2026 | 42571-317 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | TabletOral | Micro Labs Limited | Prescription drug | 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 | Prescription drug | 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 | Prescription drug | 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 | Prescription drug | 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 | Prescription drug | Oct 1, 2026 | 42571-323 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Dr.Reddys' Laboratories Inc | Over-the-counter drug | Oct 1, 2026 | 43598-946 |
| Gwyn Lonorelgestromin and ethinyl estradiol | Norelgestromin 220 ug/d; Ethinyl estradiol 20 ug/d | PatchTransdermal | Viatris Specialty LLC | Prescription drug | Oct 1, 2026 | 49502-627 |
| Giltuss TRguaifenesin,dextromethorphan hbr,phenylephrine hcl | Guaifenesin 390 mg/1 + 2 more ingredients | TabletOral | Gil Pharmaceutical Corp | Over-the-counter drug | Oct 1, 2026 | 58552-355 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | Apotex Corp | Prescription drug | Oct 1, 2026 | 60505-4956 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | American Health Packaging | Prescription drug | Oct 1, 2026 | 60687-961 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | American Health Packaging | Prescription drug | Oct 1, 2026 | 60687-972 |
| Methotrexate | Methotrexate 2.5 mg/1 | TabletOral | American Health Packaging | Prescription drug | Oct 1, 2026 | 60687-975 |