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

Recently listed finished products, newest first
ProductStrengthForm · routeLabelerListedProduct NDC
Prednisoloneprednisolone oralPrednisolone 15 mg/5mLSolutionOralTRUPHARMA, LLCAug 4, 202652817-860
Valproic AcidValproic acid 250 mg/5mLSolutionOralAmerican Health PackagingAug 4, 202660687-942
Valproic AcidValproic acid 500 mg/10mLSolutionOralAmerican Health PackagingAug 4, 202660687-953
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 10 mg/1TabletOralCoupler LLCAug 4, 202667046-0833
prazosin hydrochloridePrazosin hydrochloride 5 mg/1CapsuleOralCoupler LLCAug 4, 202667046-1050
GabapentinGabapentin 600 mg/1TabletOralCoupler LLCAug 4, 202667046-1086
Ciprofloxacin HydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLCAug 4, 202667046-1692
MontelukastMontelukast sodium 10 mg/1TabletOralCoupler LLCAug 4, 202667046-2060
FenofibrateFenofibrate 54 mg/1Tablet, Film coatedOralREMEDYREPACK INC.Aug 4, 202670518-4721
Fluvoxamine maleate extended-releaseFluvoxamine maleate 100 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.Aug 4, 202670710-1847
Fluvoxamine maleate extended-releaseFluvoxamine maleate 150 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.Aug 4, 202670710-1848
Indocyanine green—KitZydus Pharmaceuticals USA Inc.Aug 4, 202670710-2018
Fluvoxamine maleate extended-releaseFluvoxamine maleate 100 mg/1Capsule, Extended releaseOralZydus Lifesciences LimitedAug 4, 202670771-1957
Fluvoxamine maleate extended-releaseFluvoxamine maleate 150 mg/1Capsule, Extended releaseOralZydus Lifesciences LimitedAug 4, 202670771-1958
Indocyanine Green—KitZydus Lifesciences LimitedAug 4, 202670771-1961
Rifadinrifampicin—KitSanofi-Aventis U.S. LLCAug 3, 20260068-0660
Awiqliinsulin icodec-abaeInsulin icodec 700 U/mLInjection, SolutionSubcutaneousNovo Nordisk Pharmaceutical Industries, LPAug 3, 20260169-3105
Valproic AcidValproic acid 250 mg/5mLSolutionOralMajor PharmaceuticalsAug 3, 20260904-7620
Valproic AcidValproic acid 500 mg/10mLSolutionOralMajor PharmaceuticalsAug 3, 20260904-7621
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-439
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-440
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-441
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-442
PregabalinPregabalin 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-443
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.Aug 3, 202629300-444

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