FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1041
11-digit product format
713351041
Labeler code
71335
Product ID
71335-1041_02a2ff55-579a-4049-a4f4-a9373b720d4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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
71335-1041-1Gabapentin90 in 1 BOTTLETABLET, FILM COATED905
71335-1041-2Gabapentin18 in 1 BOTTLETABLET, FILM COATED185
71335-1041-3Gabapentin58 in 1 BOTTLETABLET, FILM COATED585
71335-1041-4Gabapentin60 in 1 BOTTLETABLET, FILM COATED605
71335-1041-5Gabapentin30 in 1 BOTTLETABLET, FILM COATED305
71335-1041-6Gabapentin120 in 1 BOTTLETABLET, FILM COATED1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1041-1EA - Each71335-1041863a4573-3a25-4720-b3c4-1df1795aa60512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1041GABAPENTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20240406_b4954172-5439-48fd-8348-8a2e0d2fee62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNb4954172-5439-48fd-8348-8a2e0d2fee625
310434gabapentin 800 MG Oral TabletSCDb4954172-5439-48fd-8348-8a2e0d2fee625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1041-17133510410190 TABLET, FILM COATED in 1 BOTTLE (71335-1041-1) 2019-01-290000-00-00NoNoCurrent
71335-1041-27133510410218 TABLET, FILM COATED in 1 BOTTLE (71335-1041-2) 2024-04-020000-00-00NoNoCurrent
71335-1041-37133510410358 TABLET, FILM COATED in 1 BOTTLE (71335-1041-3) 2024-04-020000-00-00NoNoCurrent
71335-1041-47133510410460 TABLET, FILM COATED in 1 BOTTLE (71335-1041-4) 2020-04-280000-00-00NoNoCurrent
71335-1041-57133510410530 TABLET, FILM COATED in 1 BOTTLE (71335-1041-5) 2019-04-080000-00-00NoNoCurrent
71335-1041-671335104106120 TABLET, FILM COATED in 1 BOTTLE (71335-1041-6) 2018-12-270000-00-00NoNoCurrent