FDA.reportPublic FDA data

Gabapentin

Product NDC
82983-423
11-digit product format
829830423
Labeler code
82983
Product ID
82983-423_1e85899c-edf0-49d0-a007-06f8e6655a43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Ajenat Pharmaceuticals LLC
Application
ANDA091286
Marketing category
ANDA
Marketing start
2025-08-06
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82983-423-47Gabapentin473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82983-423-47ML - Milliliter82983-423a990d064-15ec-4f1a-a77b-fce66286b6ea12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN02304deb-7b4a-452f-9b1a-64ca0aedbcc22
283523gabapentin 50 MG/ML Oral SolutionSCD02304deb-7b4a-452f-9b1a-64ca0aedbcc22
283523gabapentin 250 MG per 5 ML Oral SolutionSY02304deb-7b4a-452f-9b1a-64ca0aedbcc22
283523gabapentin 300 MG per 6 ML Oral SolutionSY02304deb-7b4a-452f-9b1a-64ca0aedbcc22
283523gabapentin 500 MG per 10 ML Oral SolutionSY02304deb-7b4a-452f-9b1a-64ca0aedbcc22
283523gabapentin 250 MG in 5 mL Oral SolutionPSN3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 50 MG/ML Oral SolutionSCD3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 250 MG per 5 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 300 MG per 6 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 500 MG per 10 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82983-423-4782983042347473 mL in 1 BOTTLE (82983-423-47) 473 ml2025-08-06NoNoHistorical