FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2701
11-digit product format
713352701
Labeler code
71335
Product ID
71335-2701_76524566-fed6-440a-8004-8b50d9003a08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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
71335-2701-0Gabapentin28 in 1 BOTTLETABLET, FILM COATED281
71335-2701-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED301
71335-2701-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED601
71335-2701-3Gabapentin180 in 1 BOTTLETABLET, FILM COATED1801
71335-2701-4Gabapentin90 in 1 BOTTLETABLET, FILM COATED901
71335-2701-5Gabapentin100 in 1 BOTTLETABLET, FILM COATED1001
71335-2701-6Gabapentin120 in 1 BOTTLETABLET, FILM COATED1201
71335-2701-7Gabapentin500 in 1 BOTTLETABLET, FILM COATED5001
71335-2701-8Gabapentin84 in 1 BOTTLETABLET, FILM COATED841
71335-2701-9Gabapentin112 in 1 BOTTLETABLET, FILM COATED1121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2701-1EA - Each71335-2701d7942d4e-c3f7-465c-8075-97fbb79f6f4812026-02-05
71335-2701-2EA - Each71335-2701241e7e95-16af-44e1-bad2-72faa4dd1bb412026-02-05
71335-2701-3EA - Each71335-2701833701c2-b12c-4b2e-b1e2-fd63a9e3125712026-02-05
71335-2701-4EA - Each71335-270177e40b56-d76b-4ffc-b0d1-8c29b33bc45a12026-02-05
71335-2701-6EA - Each71335-2701b60cb657-7d48-4fe7-8252-a96a119d830112026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN8f982b95-4e84-4e0c-a543-747bc3dd75311
310433gabapentin 600 MG Oral TabletSCD8f982b95-4e84-4e0c-a543-747bc3dd75311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2701-07133527010028 TABLET, FILM COATED in 1 BOTTLE (71335-2701-0) 2025-09-26NoNoHistorical
71335-2701-17133527010130 TABLET, FILM COATED in 1 BOTTLE (71335-2701-1) 2025-09-26NoNoHistorical
71335-2701-27133527010260 TABLET, FILM COATED in 1 BOTTLE (71335-2701-2) 2025-09-26NoNoHistorical
71335-2701-371335270103180 TABLET, FILM COATED in 1 BOTTLE (71335-2701-3) 2025-09-26NoNoHistorical
71335-2701-47133527010490 TABLET, FILM COATED in 1 BOTTLE (71335-2701-4) 2025-09-26NoNoHistorical
71335-2701-571335270105100 TABLET, FILM COATED in 1 BOTTLE (71335-2701-5) 2025-09-26NoNoHistorical
71335-2701-671335270106120 TABLET, FILM COATED in 1 BOTTLE (71335-2701-6) 2025-09-26NoNoHistorical
71335-2701-771335270107500 TABLET, FILM COATED in 1 BOTTLE (71335-2701-7) 2025-09-26NoNoHistorical
71335-2701-87133527010884 TABLET, FILM COATED in 1 BOTTLE (71335-2701-8) 2025-09-26NoNoHistorical
71335-2701-971335270109112 TABLET, FILM COATED in 1 BOTTLE (71335-2701-9) 2025-09-26NoNoHistorical