FDA.reportPublic FDA data

Gabapentin

Product NDC
83301-0004
11-digit product format
833010004
Labeler code
83301
Product ID
83301-0004_3ce59317-9cf6-5ae5-e063-6394a90aba6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA075477
Marketing category
ANDA
Marketing start
2023-05-01
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
Rxcui310430, 310431, 310432

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
83301-0004-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10010
83301-0004-2Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50010
83301-0004-3Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0004GABAPENTIN CAPSULE [MULLAN PHARMACEUTICAL INC.]9Current NDC, 3 package rows20250411_74474aa4-4859-42d2-92d8-f23f18b34e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN74474aa4-4859-42d2-92d8-f23f18b34e0410
310431gabapentin 300 MG Oral CapsulePSN74474aa4-4859-42d2-92d8-f23f18b34e0410
310432gabapentin 400 MG Oral CapsulePSN74474aa4-4859-42d2-92d8-f23f18b34e0410
310430gabapentin 100 MG Oral CapsuleSCD74474aa4-4859-42d2-92d8-f23f18b34e0410
310431gabapentin 300 MG Oral CapsuleSCD74474aa4-4859-42d2-92d8-f23f18b34e0410
310432gabapentin 400 MG Oral CapsuleSCD74474aa4-4859-42d2-92d8-f23f18b34e0410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83301-0004-183301000401100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-1) 100 capsule2023-05-01NoNoCurrent
83301-0004-283301000402500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-2) 500 capsule2023-05-01NoNoCurrent
83301-0004-3833010004031000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0004-3) 1000 capsule2023-05-01NoNoCurrent