FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2038
11-digit product format
713352038
Labeler code
71335
Product ID
71335-2038_37645084-9791-4ae9-bd48-116b2c3f405a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206402
Marketing category
ANDA
Marketing start
2015-11-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2038-1Gabapentin90 in 1 BOTTLETABLET90106
71335-2038-2Gabapentin18 in 1 BOTTLETABLET18106
71335-2038-3Gabapentin58 in 1 BOTTLETABLET58106
71335-2038-4Gabapentin60 in 1 BOTTLETABLET60106
71335-2038-5Gabapentin30 in 1 BOTTLETABLET30106
71335-2038-6Gabapentin120 in 1 BOTTLETABLET120106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2038-1EA - Each71335-2038d4272ebe-e477-4dab-ba80-5d41a23208be12022-06-06
71335-2038-5EA - Each71335-2038d40afb6a-1ff0-4f8e-827e-2400e23c73e312022-06-06
71335-2038-6EA - Each71335-2038febae556-af3e-48e3-a827-3d50b969dca812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2038GABAPENTIN TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 6 package rows20250226_172776c0-909e-49ce-bfe1-cf154a9458ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN172776c0-909e-49ce-bfe1-cf154a9458ba106
310434gabapentin 800 MG Oral TabletSCD172776c0-909e-49ce-bfe1-cf154a9458ba106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2038-17133520380190 TABLET in 1 BOTTLE (71335-2038-1) 90 tablet2022-03-070000-00-00NoNoCurrent
71335-2038-27133520380218 TABLET in 1 BOTTLE (71335-2038-2) 18 tablet2025-01-300000-00-00NoNoCurrent
71335-2038-37133520380358 TABLET in 1 BOTTLE (71335-2038-3) 58 tablet2025-01-300000-00-00NoNoCurrent
71335-2038-47133520380460 TABLET in 1 BOTTLE (71335-2038-4) 60 tablet2023-03-270000-00-00NoNoCurrent
71335-2038-57133520380530 TABLET in 1 BOTTLE (71335-2038-5) 30 tablet2022-01-260000-00-00NoNoCurrent
71335-2038-671335203806120 TABLET in 1 BOTTLE (71335-2038-6) 120 tablet2022-02-010000-00-00NoNoCurrent