FDA.reportPublic FDA data

Gabapentin

Product NDC
81033-123
11-digit product format
810330123
Labeler code
81033
Product ID
81033-123_3f2ba3d6-6087-eaf2-e063-6294a90a7642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA091286
Marketing category
ANDA
Marketing start
2025-08-06
Substance
GABAPENTIN
Active strength
50 mg/mL
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
GABAPENTIN50 mg/mL

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
81033-123-05Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-123-16Gabapentin473 mL in 1 BOTTLESOLUTION4731
81033-123-44Gabapentin40 in 1 CARTONSOLUTION401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-123-05ML - Milliliter81033-123bbd6a009-e04a-467c-b980-f11b13656e0c12025-10-14
81033-123-44ML - Milliliter81033-123891b43ca-9cec-436e-9073-a34c9c0f710412025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 250 MG in 5 mL Oral SolutionPSN4470a567-93a6-a293-e063-6394a90affc11
283523gabapentin 50 MG/ML Oral SolutionSCD3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 50 MG/ML Oral SolutionSCD4470a567-93a6-a293-e063-6394a90affc11
283523gabapentin 250 MG per 5 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 250 MG per 5 ML Oral SolutionSY4470a567-93a6-a293-e063-6394a90affc11
283523gabapentin 300 MG per 6 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 300 MG per 6 ML Oral SolutionSY4470a567-93a6-a293-e063-6394a90affc11
283523gabapentin 500 MG per 10 ML Oral SolutionSY3f2ba3d6-6086-eaf2-e063-6294a90a76421
283523gabapentin 500 MG per 10 ML Oral SolutionSY4470a567-93a6-a293-e063-6394a90affc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-123-05810330123055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-123-1681033012316473 mL in 1 BOTTLE (81033-123-16) 473 ml2025-09-01NoNoCurrent
81033-123-448103301234440 CUP, UNIT-DOSE in 1 CARTON (81033-123-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-123-05) 2025-09-01NoNoCurrent