FDA.reportPublic FDA data

GABAPENTIN

Product NDC
76420-617
11-digit product format
764200617
Labeler code
76420
Product ID
76420-617_068d23f0-3994-f3d5-e063-6394a90ae9a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-617-10GABAPENTIN100 in 1 BOTTLECAPSULE1001
76420-617-12GABAPENTIN120 in 1 BOTTLECAPSULE1201
76420-617-24GABAPENTIN240 in 1 BOTTLECAPSULE2401
76420-617-30GABAPENTIN30 in 1 BOTTLECAPSULE301
76420-617-60GABAPENTIN60 in 1 BOTTLECAPSULE601
76420-617-90GABAPENTIN90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-617GABAPENTIN CAPSULE [ASCLEMED USA, INC.]1Current NDC, 6 package rows20230930_5fb79774-c2d4-47ba-9a16-eb367d0fdcff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN5fb79774-c2d4-47ba-9a16-eb367d0fdcff1
310431gabapentin 300 MG Oral CapsuleSCD5fb79774-c2d4-47ba-9a16-eb367d0fdcff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-617-1076420061710100 CAPSULE in 1 BOTTLE (76420-617-10) 100 capsule2023-09-30NoNoHistorical
76420-617-1276420061712120 CAPSULE in 1 BOTTLE (76420-617-12) 120 capsule2023-09-30NoNoHistorical
76420-617-2476420061724240 CAPSULE in 1 BOTTLE (76420-617-24) 240 capsule2023-09-30NoNoHistorical
76420-617-307642006173030 CAPSULE in 1 BOTTLE (76420-617-30) 30 capsule2023-09-30NoNoHistorical
76420-617-607642006176060 CAPSULE in 1 BOTTLE (76420-617-60) 60 capsule2023-09-30NoNoHistorical
76420-617-907642006179090 CAPSULE in 1 BOTTLE (76420-617-90) 90 capsule2023-09-30NoNoHistorical