GABAPENTIN

Product NDC
81279-126
11-digit product format
812790126
Labeler code
81279
Product ID
81279-126_526cf9ed-8502-fed9-e063-6394a90adf42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Pangea Pharmaceuticals, LLC
Application
ANDA219319
Marketing category
ANDA
Marketing start
2026-05-22
Substance
GABAPENTIN
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui2739001

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81279-126-60GABAPENTIN60 in 1 BOTTLECAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739001gabapentin 200 MG Oral CapsulePSN5eff7ad8-0d31-4372-82a2-ac9f549d87961
2739001gabapentin 200 MG Oral CapsuleSCD5eff7ad8-0d31-4372-82a2-ac9f549d87961
2739001gabapentin 200 MG Oral CapsuleSY5eff7ad8-0d31-4372-82a2-ac9f549d87961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-126-608127901266060 CAPSULE in 1 BOTTLE (81279-126-60) 60 capsule2026-05-22NoNoCurrent