FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2719
11-digit product format
713352719
Labeler code
71335
Product ID
71335-2719_e32af642-d4a8-4554-b512-75bdc8790ac8
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
71335-2719-1Gabapentin90 in 1 BOTTLETABLET, FILM COATED901
71335-2719-2Gabapentin58 in 1 BOTTLETABLET, FILM COATED581
71335-2719-3Gabapentin100 in 1 BOTTLETABLET, FILM COATED1001
71335-2719-4Gabapentin120 in 1 BOTTLETABLET, FILM COATED1201
71335-2719-5Gabapentin60 in 1 BOTTLETABLET, FILM COATED601
71335-2719-6Gabapentin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2719-1EA - Each71335-27195b0dfd8f-afd3-4a58-b72b-01970414c0ee12026-04-20
71335-2719-2EA - Each71335-271958a4b896-5862-4b33-964b-3a90d54b0b7412026-04-20
71335-2719-3EA - Each71335-2719b86c2231-5936-4be3-90fd-4167a77a2c5c12026-04-20
71335-2719-4EA - Each71335-27199d3fb9a8-ec51-49e3-b47d-4a7a24d5c9b012026-04-20
71335-2719-5EA - Each71335-27196452f709-6d8d-45c2-be7b-76075c79bf2b12026-04-20
71335-2719-6EA - Each71335-2719b8a0573f-ff70-4fb6-8e5e-c2c6a5b33d0212026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNd0510d04-460c-47d1-be72-0ee32c4ac6401
310433gabapentin 600 MG Oral TabletSCDd0510d04-460c-47d1-be72-0ee32c4ac6401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2719-17133527190190 TABLET, FILM COATED in 1 BOTTLE (71335-2719-1) 2025-09-26NoNoCurrent
71335-2719-27133527190258 TABLET, FILM COATED in 1 BOTTLE (71335-2719-2) 2025-09-26NoNoCurrent
71335-2719-371335271903100 TABLET, FILM COATED in 1 BOTTLE (71335-2719-3) 2025-09-26NoNoCurrent
71335-2719-471335271904120 TABLET, FILM COATED in 1 BOTTLE (71335-2719-4) 2025-09-26NoNoCurrent
71335-2719-57133527190560 TABLET, FILM COATED in 1 BOTTLE (71335-2719-5) 2025-09-26NoNoCurrent
71335-2719-67133527190630 TABLET, FILM COATED in 1 BOTTLE (71335-2719-6) 2025-09-26NoNoCurrent