Gabapentin

Product NDC
86211-112
11-digit product format
862110112
Labeler code
86211
Product ID
86211-112_63a5fc6d-ca57-4726-b70d-805ac023d959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
JVET PHARMACEUTICALS LLC
Application
ANDA091286
Marketing category
ANDA
Marketing start
2025-12-15
Substance
GABAPENTIN
Active strength
250 mg/5mL
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
GABAPENTIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui283523

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
86211-112-01Gabapentin473 mL in 1 BOTTLESOLUTION4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN63a5fc6d-ca57-4726-b70d-805ac023d9591
283523gabapentin 50 MG/ML Oral SolutionSCD63a5fc6d-ca57-4726-b70d-805ac023d9591
283523gabapentin 250 MG per 5 ML Oral SolutionSY63a5fc6d-ca57-4726-b70d-805ac023d9591
283523gabapentin 300 MG per 6 ML Oral SolutionSY63a5fc6d-ca57-4726-b70d-805ac023d9591
283523gabapentin 500 MG per 10 ML Oral SolutionSY63a5fc6d-ca57-4726-b70d-805ac023d9591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
86211-112-0186211011201473 mL in 1 BOTTLE (86211-112-01) 473 ml2025-12-15NoNoCurrent