Gabapentin

Product NDC
76420-014
11-digit product format
764200014
Labeler code
76420
Product ID
76420-014_ead11d10-7482-8d9b-e053-2a95a90a2c68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA075350
Marketing category
ANDA
Marketing start
2014-04-23
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431

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
76420-014-30Gabapentin30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-014GABAPENTIN CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20221013_e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsulePSNe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310430gabapentin 100 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82
310431gabapentin 300 MG Oral CapsuleSCDe89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-014-307642000143030 CAPSULE in 1 BOTTLE (76420-014-30) 30 capsule2020-01-230000-00-00NoNoCurrent