Gabapentin

Product NDC
63629-7309
11-digit product format
636297309
Labeler code
63629
Product ID
63629-7309_130f4b5b-eefe-4ce6-8555-c872a8082c17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075350
Marketing category
ANDA
Marketing start
2014-04-03
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7309-12024-01-30C16284748780-11030e365-0442-111a-e063-dadaa90a10e2These 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
63629-7309-22024-01-30C16284748780-11030e365-0442-111a-e063-dadaa90a10e2These 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
63629-7309-32024-01-30C16284748780-11030e365-0442-111a-e063-dadaa90a10e2These 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
63629-7309-42024-01-30C16284748780-11030e365-0442-111a-e063-dadaa90a10e2These 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
63629-7309-52024-01-30C16284748780-11030e365-0442-111a-e063-dadaa90a10e2These 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
63629-7309-1Gabapentin90 in 1 BOTTLECAPSULE9026
63629-7309-2Gabapentin28 in 1 BOTTLECAPSULE2826
63629-7309-3Gabapentin120 in 1 BOTTLECAPSULE12026
63629-7309-4Gabapentin30 in 1 BOTTLECAPSULE3026
63629-7309-5Gabapentin60 in 1 BOTTLECAPSULE6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7309-1EA - Each63629-730981dcf137-4917-41c0-9515-a9a0e050aa7912019-10-07
63629-7309-2EA - Each63629-7309921f5301-c500-444a-acbb-d410d85bbfe112019-10-07
63629-7309-3EA - Each63629-7309f8da7f98-d106-443c-8906-1b9274d9e5fb12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7309GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]26Legacy NDC, 5 package rows20220224_130f4b5b-eefe-4ce6-8555-c872a8082c17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN130f4b5b-eefe-4ce6-8555-c872a8082c1726
310432gabapentin 400 MG Oral CapsuleSCD130f4b5b-eefe-4ce6-8555-c872a8082c1726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7309-16362973090190 CAPSULE in 1 BOTTLE (63629-7309-1) 90 capsule2017-07-140000-00-00NoNoCurrent
63629-7309-26362973090228 CAPSULE in 1 BOTTLE (63629-7309-2) 28 capsule2022-02-210000-00-00NoNoCurrent
63629-7309-363629730903120 CAPSULE in 1 BOTTLE (63629-7309-3) 120 capsule2018-10-040000-00-00NoNoCurrent
63629-7309-46362973090430 CAPSULE in 1 BOTTLE (63629-7309-4) 30 capsule2019-11-200000-00-00NoNoCurrent
63629-7309-56362973090560 CAPSULE in 1 BOTTLE (63629-7309-5) 60 capsule2020-01-230000-00-00NoNoCurrent