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 |
|---|---|---|---|---|---|
| Brimonidine Tartrate and Timolol maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Devatis Inc. | Sep 15, 2026 | 73043-029 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Northwind Health Company, LLC | Sep 15, 2026 | 82868-088 |
| Metaxalone | Metaxalone 400 mg/1 | TabletOral | Blue Heron Pharmaceuticals, LLC | Sep 15, 2026 | 85622-950 |
| Orablocarticaine hydrochloride and epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL | InjectionSubmucosal | Aira LLC | Sep 15, 2026 | 87566-110 |
| Orablocarticaine hydrochloride and epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL | InjectionSubmucosal | Aira LLC | Sep 15, 2026 | 87566-120 |
| Beclomethasone Dipropionate | Beclomethasone dipropionate 40 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Aurolife Pharma LLC | Sep 14, 2026 | 13107-230 |
| Beclomethasone Dipropionate | Beclomethasone dipropionate 80 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Aurolife Pharma LLC | Sep 14, 2026 | 13107-231 |
| Haloperidol | Haloperidol .5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-264 |
| Haloperidol | Haloperidol 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-265 |
| Haloperidol | Haloperidol 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-266 |
| Haloperidol | Haloperidol 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-267 |
| Haloperidol | Haloperidol 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-268 |
| Haloperidol | Haloperidol 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | Sep 14, 2026 | 27241-269 |
| Benzonatate 100 mgbenzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | Sep 14, 2026 | 49483-946 |
| Benzonatate 200 mgbenzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | Sep 14, 2026 | 49483-947 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | BPI Labs LLC | Sep 14, 2026 | 54288-150 |
| testosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | BPI Labs LLC | Sep 14, 2026 | 54288-156 |
| mycophenolate mofetil | Mycophenolate mofetil 250 mg/1 | CapsuleOral | Cardinal Health 107, LLC | Sep 14, 2026 | 55154-0161 |
| Hydralazine Hydrochloride | Hydralazine hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | Sep 14, 2026 | 55154-0287 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | Sep 14, 2026 | 55154-0289 |
| Bexlutrylutetium oxodotreotide lu-177 | Lutetium oxodotreotide lu-177 10 mCi/mL | InjectionIntravenous | Curium US LLC | Sep 14, 2026 | 69945-177 |
| Montelukast Sodium | Montelukast sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | Sep 14, 2026 | 70518-4753 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvKARE | Sep 14, 2026 | 73190-081 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | AvKARE | Sep 14, 2026 | 73190-082 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvKARE | Sep 14, 2026 | 73190-083 |