FDA.reportPublic FDA data

Gabapentin

Product NDC
63629-7307
11-digit product format
636297307
Labeler code
63629
Product ID
63629-7307_bf3970ae-aad4-4040-a05d-0f4772007586
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7307-12024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-22024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-32024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-42024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-52024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-62024-10-21C16284748780-19d75b9d0-7534-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
63629-7307-12024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-22024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-32024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-42024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-52024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-62024-01-30C16284748780-19d75b9d0-7534-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
63629-7307-12022-02-16C16284748780-19d75b9d0-7534-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
63629-7307-22022-02-16C16284748780-19d75b9d0-7534-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
63629-7307-32022-02-16C16284748780-19d75b9d0-7534-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
63629-7307-42022-02-16C16284748780-19d75b9d0-7534-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
63629-7307-52022-02-16C16284748780-19d75b9d0-7534-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
63629-7307-12020-01-31C16284748780-19d75b9d0-7534-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
63629-7307-22020-01-31C16284748780-19d75b9d0-7534-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
63629-7307-32020-01-31C16284748780-19d75b9d0-7534-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
63629-7307-42020-01-31C16284748780-19d75b9d0-7534-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
63629-7307-52020-01-31C16284748780-19d75b9d0-7534-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
63629-7307-1Gabapentin90 in 1 BOTTLETABLET9011
63629-7307-2Gabapentin58 in 1 BOTTLETABLET5811
63629-7307-3Gabapentin100 in 1 BOTTLETABLET10011
63629-7307-4Gabapentin120 in 1 BOTTLETABLET12011
63629-7307-5Gabapentin60 in 1 BOTTLETABLET6011
63629-7307-6Gabapentin30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7307-1EA - Each63629-73079ddb5cb7-0f5b-491e-88e4-42b42a60232212018-06-11
63629-7307-2EA - Each63629-73076b8d9462-b29b-4198-98e7-1ebd06b5e45d12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7307GABAPENTIN TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 6 package rows20241023_137b2b9a-9d42-48d0-913f-5dc146fb689a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN137b2b9a-9d42-48d0-913f-5dc146fb689a11
310433gabapentin 600 MG Oral TabletSCD137b2b9a-9d42-48d0-913f-5dc146fb689a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7307-16362973070190 TABLET in 1 BOTTLE (63629-7307-1) 90 tablet2017-06-300000-00-00NoNoCurrent
63629-7307-26362973070258 TABLET in 1 BOTTLE (63629-7307-2) 58 tablet2024-10-080000-00-00NoNoCurrent
63629-7307-363629730703100 TABLET in 1 BOTTLE (63629-7307-3) 100 tablet2018-07-300000-00-00NoNoCurrent
63629-7307-463629730704120 TABLET in 1 BOTTLE (63629-7307-4) 120 tablet2018-08-070000-00-00NoNoCurrent
63629-7307-56362973070560 TABLET in 1 BOTTLE (63629-7307-5) 60 tablet2018-11-070000-00-00NoNoCurrent
63629-7307-66362973070630 TABLET in 1 BOTTLE (63629-7307-6) 30 tablet2024-10-080000-00-00NoNoCurrent