FDA.reportPublic FDA data

Gabapentin

Product NDC
53002-6423
11-digit product format
530026423
Labeler code
53002
Product ID
53002-6423_6c125ce5-3188-4f43-b35b-6f31639cbad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-6423-02025-01-30C16284748780-12cef2736-7aed-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
53002-6423-32025-01-30C16284748780-12cef2736-7aed-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
53002-6423-62025-01-30C16284748780-12cef2736-7aed-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-6423-0Gabapentin100 in 1 BOTTLECAPSULE1001
53002-6423-3Gabapentin30 in 1 BOTTLECAPSULE301
53002-6423-6Gabapentin60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6423GABAPENTIN CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_c300bb3e-a556-4094-9114-6f9ecff2d77c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNc300bb3e-a556-4094-9114-6f9ecff2d77c1
310431gabapentin 300 MG Oral CapsuleSCDc300bb3e-a556-4094-9114-6f9ecff2d77c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-6423-053002642300100 CAPSULE in 1 BOTTLE (53002-6423-0) 100 capsule2021-01-010000-00-00NoNoCurrent
53002-6423-35300264230330 CAPSULE in 1 BOTTLE (53002-6423-3) 30 capsule2021-01-010000-00-00NoNoCurrent
53002-6423-65300264230660 CAPSULE in 1 BOTTLE (53002-6423-6) 60 capsule2021-01-010000-00-00NoNoCurrent