FDA.reportPublic FDA data

Gabapentin

Product NDC
83301-0002
11-digit product format
833010002
Labeler code
83301
Product ID
83301-0002_423fc29b-e05c-0d6b-e063-6294a90abf30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA207057
Marketing category
ANDA
Marketing start
2024-01-01
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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
83301-0002-1Gabapentin100 in 1 BOTTLE, PLASTICTABLET, COATED1004
83301-0002-2Gabapentin500 in 1 BOTTLE, PLASTICTABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0002GABAPENTIN TABLET, COATED [MULLAN PHARMACEUTICAL INC.]3Current NDC, 2 package rows20250223_47a22de2-ec66-45be-8648-89ed3ab6e67e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN47a22de2-ec66-45be-8648-89ed3ab6e67e4
310434gabapentin 800 MG Oral TabletPSN47a22de2-ec66-45be-8648-89ed3ab6e67e4
310433gabapentin 600 MG Oral TabletSCD47a22de2-ec66-45be-8648-89ed3ab6e67e4
310434gabapentin 800 MG Oral TabletSCD47a22de2-ec66-45be-8648-89ed3ab6e67e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83301-0002-183301000201100 TABLET, COATED in 1 BOTTLE, PLASTIC (83301-0002-1) 2024-01-01NoNoCurrent
83301-0002-283301000202500 TABLET, COATED in 1 BOTTLE, PLASTIC (83301-0002-2) 2024-01-01NoNoCurrent