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 |
|---|---|---|---|---|---|
| Trospium Chloride | Trospium chloride 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | Oct 8, 2026 | 70518-4768 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | Oct 8, 2026 | 70518-4769 |
| Fidaxomicin | Fidaxomicin 200 mg/1 | Tablet, CoatedOral | Hikma Pharmceuticals USA Inc. | Oct 7, 2026 | 0054-0795 |
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | Oct 7, 2026 | 0054-0824 |
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | Oct 7, 2026 | 0054-0825 |
| Deflazacort | Deflazacort 30 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | Oct 7, 2026 | 0054-0826 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | Oct 7, 2026 | 0054-0827 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | Oct 7, 2026 | 55154-0577 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/5mL | SolutionOral | Advagen Pharma Ltd | Oct 7, 2026 | 72888-491 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | Oct 6, 2026 | 0480-3444 |
| Allopurinol | Allopurinol 100 mg/1 | TabletOral | AvPAK | Oct 6, 2026 | 50268-030 |
| Allopurinol | Allopurinol 300 mg/1 | TabletOral | AvPAK | Oct 6, 2026 | 50268-031 |
| Urea 20% | Urea 200 mg/g | CreamTopical | PureTek Corporation | Oct 6, 2026 | 59088-258 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | Oct 6, 2026 | 60760-997 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Coupler LLC | Oct 6, 2026 | 67046-1294 |
| Clonazepam | Clonazepam 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | Oct 6, 2026 | 68788-8781 |
| cevimeline hydrochloride | Cevimeline hydrochloride 30 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | Oct 5, 2026 | 0054-0893 |
| Uribel Tabsmethenamine, benzoic acid, phenyl salicylate, methylene blue, hyoscyamine sulfate | Methenamine 81.6 mg/1 + 4 more ingredients | TabletOral | Cintex Services, LLC | Oct 5, 2026 | 24470-967 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Dr.Reddys Laboratories Inc | Oct 5, 2026 | 43598-032 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | Oct 5, 2026 | 70518-4767 |
| Omlycloomalizumab-igec | Omalizumab 75 mg/.5mL | InjectionSubcutaneous | CELLTRION USA, Inc. | Oct 5, 2026 | 72606-035 |
| Omlycloomalizumab-igec | Omalizumab 150 mg/mL | InjectionSubcutaneous | CELLTRION USA, Inc. | Oct 5, 2026 | 72606-036 |
| Omlycloomalizumab-igec | Omalizumab 300 mg/2mL | InjectionSubcutaneous | CELLTRION USA, Inc. | Oct 5, 2026 | 72606-054 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Carol Way Pharma LLC | Oct 4, 2026 | 85437-013 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | Oct 2, 2026 | 67046-1695 |