GABAPENTIN

Product NDC
67296-1710
11-digit product format
672961710
Labeler code
67296
Product ID
67296-1710_b8dfb680-8a9a-5315-e053-2995a90aa59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2019-11-01
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
2022-12-31
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
67296-1710-62023-01-30C16284748780-1f386c649-b780-0266-e053-dadaa90a7c1aGabapentin 300mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1710-6GABAPENTIN60 in 1 BOTTLECAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1710GABAPENTIN CAPSULE [REDPHARM DRUG, INC.]8Legacy NDC, 1 package rows20210115_96cab001-3d67-17f7-e053-2a95a90a2e23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN96cab001-3d67-17f7-e053-2a95a90a2e238
310431gabapentin 300 MG Oral CapsuleSCD96cab001-3d67-17f7-e053-2a95a90a2e238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1710-66729617100660 CAPSULE in 1 BOTTLE (67296-1710-6) 60 capsule2019-11-010000-00-00NoNoCurrent