GABAPENTIN

Product NDC
76420-020
11-digit product format
764200020
Labeler code
76420
Product ID
76420-020_a7b785f9-4f75-92ed-e053-2995a90a9fa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2017-12-05
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
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
76420-020-24GABAPENTIN240 in 1 BOTTLECAPSULE2401
76420-020-30GABAPENTIN30 in 1 BOTTLECAPSULE301
76420-020-60GABAPENTIN60 in 1 BOTTLECAPSULE601
76420-020-90GABAPENTIN90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-020GABAPENTIN CAPSULE [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 4 package rows20200611_45039bba-7a96-450c-95be-83a3aa4fcbd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN45039bba-7a96-450c-95be-83a3aa4fcbd21
310431gabapentin 300 MG Oral CapsuleSCD45039bba-7a96-450c-95be-83a3aa4fcbd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-020-2476420002024240 CAPSULE in 1 BOTTLE (76420-020-24) 240 capsule2020-06-100000-00-00NoNoCurrent
76420-020-307642000203030 CAPSULE in 1 BOTTLE (76420-020-30) 30 capsule2020-06-100000-00-00NoNoCurrent
76420-020-607642000206060 CAPSULE in 1 BOTTLE (76420-020-60) 60 capsule2020-06-100000-00-00NoNoCurrent
76420-020-907642000209090 CAPSULE in 1 BOTTLE (76420-020-90) 90 capsule2020-06-100000-00-00NoNoCurrent