FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1496
11-digit product format
713351496
Labeler code
71335
Product ID
71335-1496_3b016d02-362e-4b97-934e-4eceaceca0df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

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
71335-1496-1Gabapentin90 in 1 BOTTLECAPSULE90105
71335-1496-2Gabapentin28 in 1 BOTTLECAPSULE28105
71335-1496-3Gabapentin120 in 1 BOTTLECAPSULE120105
71335-1496-4Gabapentin30 in 1 BOTTLECAPSULE30105
71335-1496-5Gabapentin60 in 1 BOTTLECAPSULE60105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1496-1EA - Each71335-14968e9b1a18-dbf2-4fa7-987e-0c3c73bfb69b12022-06-06
71335-1496-3EA - Each71335-14967264f53b-6f3f-45f5-937b-5a5ae283761b12022-06-06
71335-1496-4EA - Each71335-14966e8afbb5-3db3-4b24-adc9-32f78499064812022-06-06
71335-1496-5EA - Each71335-1496d4af5c45-a781-46be-aeac-55d835723d2112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1496GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 5 package rows20250327_f0e7a6c9-ae6c-4259-81ab-a37db54e3c80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNf0e7a6c9-ae6c-4259-81ab-a37db54e3c80105
310432gabapentin 400 MG Oral CapsuleSCDf0e7a6c9-ae6c-4259-81ab-a37db54e3c80105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1496-17133514960190 CAPSULE in 1 BOTTLE (71335-1496-1) 90 capsule2020-02-040000-00-00NoNoCurrent
71335-1496-27133514960228 CAPSULE in 1 BOTTLE (71335-1496-2) 28 capsule2025-01-300000-00-00NoNoCurrent
71335-1496-371335149603120 CAPSULE in 1 BOTTLE (71335-1496-3) 120 capsule2022-01-270000-00-00NoNoCurrent
71335-1496-47133514960430 CAPSULE in 1 BOTTLE (71335-1496-4) 30 capsule2020-11-090000-00-00NoNoCurrent
71335-1496-57133514960560 CAPSULE in 1 BOTTLE (71335-1496-5) 60 capsule2022-01-260000-00-00NoNoCurrent