FDA.reportPublic FDA data

Gabapentin

Product NDC
63629-3063
11-digit product format
636293063
Labeler code
63629
Product ID
63629-3063_f8194665-0d50-4ebd-8c82-5df9c2c8b3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-3063-02020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-12020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-22020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-32020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-42020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-52020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-62020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-72020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-82020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-92020-02-25C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-02020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-12020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-22020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-32020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-42020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-52020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-62020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-72020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-82020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-92020-01-31C16284748780-19d75b9d0-0c79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3063-0Gabapentin45 in 1 BOTTLETABLET4519
63629-3063-1Gabapentin30 in 1 BOTTLETABLET3019
63629-3063-2Gabapentin60 in 1 BOTTLETABLET6019
63629-3063-3Gabapentin180 in 1 BOTTLETABLET18019
63629-3063-4Gabapentin90 in 1 BOTTLETABLET9019
63629-3063-5Gabapentin100 in 1 BOTTLETABLET10019
63629-3063-6Gabapentin120 in 1 BOTTLETABLET12019
63629-3063-7Gabapentin56 in 1 BOTTLETABLET5619
63629-3063-8Gabapentin84 in 1 BOTTLETABLET8419
63629-3063-9Gabapentin112 in 1 BOTTLETABLET11219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3063-1EA - Each63629-30632d0d8707-c28b-4f6e-9e3b-bd173fc2db4612012-07-24
63629-3063-2EA - Each63629-306363161452-fd11-48fa-99dc-11235436719312012-07-24
63629-3063-3EA - Each63629-3063c5760a30-63f5-4844-9b79-5c4e788a6f2212012-07-24
63629-3063-4EA - Each63629-30639a9b270f-6955-4176-aef0-b9ad40374acc12012-07-24
63629-3063-5EA - Each63629-306393e2d1dd-625e-4c7b-876b-9b7068c9f13a12012-07-24
63629-3063-6EA - Each63629-3063fea6bc8f-9afe-4318-b629-18953c874fc912012-07-24
63629-3063-7EA - Each63629-3063699dc091-3149-4b20-910e-b423ae5ab99412015-02-02
63629-3063-8EA - Each63629-306383c1ac21-70e6-4aaa-b747-40762c001d3512015-02-02
63629-3063-9EA - Each63629-3063e9c81794-8880-4697-8a3a-a577fc3bc4b412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [BRYANT RANCH PREPACK]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN632cb507-5675-2392-0460-b09c0dd1465019
310433gabapentin 600 MG Oral TabletSCD632cb507-5675-2392-0460-b09c0dd1465019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3063-06362930630045 TABLET in 1 BOTTLE (63629-3063-0) 45 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-16362930630130 TABLET in 1 BOTTLE (63629-3063-1) 30 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-26362930630260 TABLET in 1 BOTTLE (63629-3063-2) 60 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-363629306303180 TABLET in 1 BOTTLE (63629-3063-3) 180 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-46362930630490 TABLET in 1 BOTTLE (63629-3063-4) 90 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-563629306305100 TABLET in 1 BOTTLE (63629-3063-5) 100 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-663629306306120 TABLET in 1 BOTTLE (63629-3063-6) 120 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-76362930630756 TABLET in 1 BOTTLE (63629-3063-7) 56 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-86362930630884 TABLET in 1 BOTTLE (63629-3063-8) 84 tablet2026-04-070000-00-00NoNoCurrent
63629-3063-963629306309112 TABLET in 1 BOTTLE (63629-3063-9) 112 tablet2026-04-070000-00-00NoNoCurrent