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
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-327
TopiramateTopiramate 150 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-328
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-329
TrentalpentoxifyllinePentoxifylline 400 mg/1Tablet, Extended releaseOralValidus Pharmaceuticals LLCOct 1, 202630698-006
DapagliflozinDapagliflozin 5 mg/1TabletOralMicro Labs LimitedOct 1, 202642571-317
DapagliflozinDapagliflozin 10 mg/1TabletOralMicro Labs LimitedOct 1, 202642571-318
Dapagliflozin and Metformin HydrochlorideDapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coated, Extended releaseOralMicro Labs LimitedOct 1, 202642571-320
Dapagliflozin and Metformin HydrochlorideDapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coated, Extended releaseOralMicro Labs LimitedOct 1, 202642571-321
Dapagliflozin and Metformin HydrochlorideDapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coated, Extended releaseOralMicro Labs LimitedOct 1, 202642571-322
Dapagliflozin and Metformin HydrochlorideDapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coated, Extended releaseOralMicro Labs LimitedOct 1, 202642571-323
Gwyn Lonorelgestromin and ethinyl estradiolNorelgestromin 220 ug/d; Ethinyl estradiol 20 ug/dPatchTransdermalViatris Specialty LLCOct 1, 202649502-627
Ertapenemertapenem sodiumErtapenem sodium 1 g/20mLInjectionIntramuscular, IntravenousApotex CorpOct 1, 202660505-4956
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralAmerican Health PackagingOct 1, 202660687-961
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralAmerican Health PackagingOct 1, 202660687-972
MethotrexateMethotrexate 2.5 mg/1TabletOralAmerican Health PackagingOct 1, 202660687-975
Nicardipine HydrochlorideNicardipine hydrochloride .1 mg/mLInjectionIntravenousFresenius Kabi USA, LLCOct 1, 202665219-296
Nicardipine HydrochlorideNicardipine hydrochloride .2 mg/mLInjectionIntravenousFresenius Kabi USA, LLCOct 1, 202665219-298
Hercessitrastuzumab-strf—KitAccord BioPharma Inc.Oct 1, 202669448-035
RivaroxabanRivaroxaban 2.5 mg/1TabletOralLifestar Pharma LLCOct 1, 202670756-006
Thiamine HydrochlorideThiamine hydrochloride 100 mg/mLInjection, SolutionIntramuscular, IntravenousLifestar Pharma LLCOct 1, 202670756-684
TretinoinTretinoin .25 mg/gCreamTopicalZydus Lifesciences LimitedOct 1, 202670771-1933
MacitentanMacitentan 10 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.Oct 1, 202670954-025
Fosfomycin TromethamineFosfomycin tromethamine 3 g/1Granule, For solutionOralANI Pharmaceuticals, Inc.Oct 1, 202670954-040
TretinoinTretinoin .25 mg/gCreamTopicalViona Pharmaceuticals IncOct 1, 202672578-155
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralNorthStar Rx LLCOct 1, 202672603-564

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