FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-2521
11-digit product format
713352521
Labeler code
71335
Product ID
71335-2521_9e261ec8-4838-464b-a004-0f9ce246c760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2521-0GABAPENTIN20 in 1 BOTTLECAPSULE202
71335-2521-1GABAPENTIN30 in 1 BOTTLECAPSULE302
71335-2521-2GABAPENTIN90 in 1 BOTTLECAPSULE902
71335-2521-3GABAPENTIN60 in 1 BOTTLECAPSULE602
71335-2521-4GABAPENTIN120 in 1 BOTTLECAPSULE1202
71335-2521-5GABAPENTIN100 in 1 BOTTLECAPSULE1002
71335-2521-6GABAPENTIN28 in 1 BOTTLECAPSULE282
71335-2521-7GABAPENTIN112 in 1 BOTTLECAPSULE1122
71335-2521-8GABAPENTIN84 in 1 BOTTLECAPSULE842
71335-2521-9GABAPENTIN180 in 1 BOTTLECAPSULE1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2521GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250223_35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012
310431gabapentin 300 MG Oral CapsuleSCD35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2521-07133525210020 CAPSULE in 1 BOTTLE (71335-2521-0) 20 capsule2024-11-04NoNoHistorical
71335-2521-17133525210130 CAPSULE in 1 BOTTLE (71335-2521-1) 30 capsule2024-11-04NoNoHistorical
71335-2521-27133525210290 CAPSULE in 1 BOTTLE (71335-2521-2) 90 capsule2024-11-04NoNoHistorical
71335-2521-37133525210360 CAPSULE in 1 BOTTLE (71335-2521-3) 60 capsule2024-11-04NoNoHistorical
71335-2521-471335252104120 CAPSULE in 1 BOTTLE (71335-2521-4) 120 capsule2024-11-04NoNoHistorical
71335-2521-571335252105100 CAPSULE in 1 BOTTLE (71335-2521-5) 100 capsule2024-11-04NoNoHistorical
71335-2521-67133525210628 CAPSULE in 1 BOTTLE (71335-2521-6) 28 capsule2024-11-04NoNoHistorical
71335-2521-771335252107112 CAPSULE in 1 BOTTLE (71335-2521-7) 112 capsule2024-11-04NoNoHistorical
71335-2521-87133525210884 CAPSULE in 1 BOTTLE (71335-2521-8) 84 capsule2024-11-04NoNoHistorical
71335-2521-971335252109180 CAPSULE in 1 BOTTLE (71335-2521-9) 180 capsule2024-11-04NoNoHistorical