FDA.reportPublic FDA data

Gabapentin

Product NDC
63629-7306
11-digit product format
636297306
Labeler code
63629
Product ID
63629-7306_f11fbdbf-9fbc-49ef-8296-44be1c9d7a03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

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
63629-7306-12020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-22020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-32020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-42020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-52020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-62020-02-25C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-12020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-22020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-32020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-42020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-52020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
63629-7306-62020-01-31C16284748780-19d75b9d0-639d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7306-1Gabapentin90 in 1 BOTTLECAPSULE9018
63629-7306-2Gabapentin28 in 1 BOTTLECAPSULE2818
63629-7306-3Gabapentin58 in 1 BOTTLECAPSULE5818
63629-7306-4Gabapentin30 in 1 BOTTLECAPSULE3018
63629-7306-5Gabapentin60 in 1 BOTTLECAPSULE6018
63629-7306-6Gabapentin120 in 1 BOTTLECAPSULE12018
63629-7306-7Gabapentin180 in 1 BOTTLECAPSULE18018
63629-7306-8Gabapentin40 in 1 BOTTLECAPSULE4018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7306GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 8 package rows20241109_506bf880-9564-404c-951a-703797ffdad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN506bf880-9564-404c-951a-703797ffdad818
310431gabapentin 300 MG Oral CapsuleSCD506bf880-9564-404c-951a-703797ffdad818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7306-16362973060190 CAPSULE in 1 BOTTLE (63629-7306-1) 90 capsule2017-06-300000-00-00NoNoCurrent
63629-7306-26362973060228 CAPSULE in 1 BOTTLE (63629-7306-2) 28 capsule2024-10-290000-00-00NoNoCurrent
63629-7306-36362973060358 CAPSULE in 1 BOTTLE (63629-7306-3) 58 capsule2024-10-290000-00-00NoNoCurrent
63629-7306-46362973060430 CAPSULE in 1 BOTTLE (63629-7306-4) 30 capsule2017-09-140000-00-00NoNoCurrent
63629-7306-56362973060560 CAPSULE in 1 BOTTLE (63629-7306-5) 60 capsule2018-08-090000-00-00NoNoCurrent
63629-7306-663629730606120 CAPSULE in 1 BOTTLE (63629-7306-6) 120 capsule2018-08-070000-00-00NoNoCurrent
63629-7306-763629730607180 CAPSULE in 1 BOTTLE (63629-7306-7) 180 capsule2024-10-290000-00-00NoNoCurrent
63629-7306-86362973060840 CAPSULE in 1 BOTTLE (63629-7306-8) 40 capsule2024-10-290000-00-00NoNoCurrent