GABAPENTIN

Product NDC
67296-1638
11-digit product format
672961638
Labeler code
67296
Product ID
67296-1638_b8d0a08f-8077-1f4e-e053-2a95a90a62e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090007
Marketing category
ANDA
Marketing start
2019-01-01
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
67296-1638-22023-01-30C16284748780-1f386c649-ea84-0266-e053-dadaa90a7c1aGABAPENTIN 300MG
67296-1638-62023-01-30C16284748780-1f386c649-ea84-0266-e053-dadaa90a7c1aGABAPENTIN 300MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1638-2GABAPENTIN20 in 1 BOTTLECAPSULE203
67296-1638-6GABAPENTIN60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1638GABAPENTIN CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20210114_88ddd50d-1762-2880-e053-2995a90adf67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN88ddd50d-1762-2880-e053-2995a90adf673
310431gabapentin 300 MG Oral CapsuleSCD88ddd50d-1762-2880-e053-2995a90adf673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1638-26729616380220 CAPSULE in 1 BOTTLE (67296-1638-2) 20 capsule2019-01-010000-00-00NoNoCurrent
67296-1638-66729616380660 CAPSULE in 1 BOTTLE (67296-1638-6) 60 capsule2019-11-010000-00-00NoNoCurrent