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
Genglycospariglasgene brecaparvovec-opnr—KitUltragenyx Pharmaceutical Inc.Sep 17, 202669794-345
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularREMEDYREPACK INC.Sep 17, 202670518-4755
GentamicinGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousREMEDYREPACK INC.Sep 17, 202670518-4757
Dextromethorphan hydrobromide and quinidine sulfateDextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1CapsuleOralTeva Pharmaceuticals, Inc.Sep 16, 20260480-2602
GeodonziprasidoneZiprasidone 40 mg/1CapsuleOralViatris Specialty LLCSep 16, 202658151-132
NaproxenNaproxen 500 mg/1TabletOralSt. Mary's Medical Park PharmacySep 16, 202660760-190
TemozolomideTemozolomide 100 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2005
TemozolomideTemozolomide 140 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2007
TemozolomideTemozolomide 180 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2009
TemozolomideTemozolomide 250 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2011
CyclophosphamideCyclophosphamide 25 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2013
CyclophosphamideCyclophosphamide 50 mg/1CapsuleOralOPKO Pharmaceuticals, LLCSep 16, 202670301-2015
OfloxacinOfloxacin 3 mg/mLSolutionAuricular (Otic)REMEDYREPACK INC.Sep 16, 202670518-4752
Folic AcidFolic acid 1 mg/1TabletOralREMEDYREPACK INC.Sep 16, 202670518-4756
dicyclomine hydrochlorideDicyclomine hydrochloride 10 mg/1CapsuleOralHikma Pharmaceuticals USA Inc.Sep 15, 20260054-0883
Milnacipran HydrochlorideMilnacipran hydrochloride 12.5 mg/1TabletOralMacleods Pharmaceuticals LimitedSep 15, 202633342-369
Milnacipran HydrochlorideMilnacipran hydrochloride 25 mg/1TabletOralMacleods Pharmaceuticals LimitedSep 15, 202633342-370
Milnacipran HydrochlorideMilnacipran hydrochloride 50 mg/1TabletOralMacleods Pharmaceuticals LimitedSep 15, 202633342-371
Milnacipran HydrochlorideMilnacipran hydrochloride 100 mg/1TabletOralMacleods Pharmaceuticals LimitedSep 15, 202633342-372
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLCSep 15, 202667877-737
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLCSep 15, 202667877-738
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLCSep 15, 202667877-739
Olmesartan medoxomil and hydrochlorothiazideOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.Sep 15, 202670518-4754
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/20mLInjection, SolutionIntravenousArmas Pharmaceuticals Inc.Sep 15, 202672485-515
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularArmas Pharmaceuticals Inc.Sep 15, 202672485-525

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