FDA.reportPublic FDA data

GABAPENTIN

Product NDC
72737-005
11-digit product format
727370005
Labeler code
72737
Product ID
72737-005_30d4f239-f37b-4b6e-b25e-043a33489011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
STALLION LABORATORIES PRIVATE LIMITED
Application
ANDA219319
Marketing category
ANDA
Marketing start
2025-08-07
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
72737-005-01GABAPENTIN30 in 1 BOTTLECAPSULE302
72737-005-02GABAPENTIN100 in 1 BOTTLECAPSULE1002
72737-005-03GABAPENTIN500 in 1 BOTTLECAPSULE5002
72737-005-04GABAPENTIN1000 in 1 BOTTLECAPSULE10002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92
310431gabapentin 300 MG Oral CapsulePSNb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92
310432gabapentin 400 MG Oral CapsulePSNb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92
310430gabapentin 100 MG Oral CapsuleSCDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92
310431gabapentin 300 MG Oral CapsuleSCDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92
310432gabapentin 400 MG Oral CapsuleSCDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72737-005-017273700050130 CAPSULE in 1 BOTTLE (72737-005-01) 30 capsule2025-08-07NoNoCurrent
72737-005-0272737000502100 CAPSULE in 1 BOTTLE (72737-005-02) 100 capsule2025-08-07NoNoCurrent
72737-005-0372737000503500 CAPSULE in 1 BOTTLE (72737-005-03) 500 capsule2025-08-07NoNoCurrent
72737-005-04727370005041000 CAPSULE in 1 BOTTLE (72737-005-04) 1000 capsule2025-08-07NoNoCurrent