FDA.reportPublic FDA data

Gabapentin

Product NDC
81033-123
Requested package NDC
81033-123-44
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091286-001GABAPENTINGABAPENTIN250MG/5MLSOLUTION / ORALAA2016-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091286-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091286-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2016-03-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091286-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAjenat Pharmaceuticals LLC02304deb-7b4a-452f-9b1a-64ca0aedbcc22025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091286
application number: ANDA091286
GabapentinGABAPENTINJVET PHARMACEUTICALS LLC63a5fc6d-ca57-4726-b70d-805ac023d9592025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091286
application number: ANDA091286
GabapentinGABAPENTINKesin Pharma Corporation4470a567-93a6-a293-e063-6394a90affc12025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091286
application number: ANDA091286
ndc (product): 81033-123
GabapentinGABAPENTINKesin Pharma Corporation3f2ba3d6-6086-eaf2-e063-6294a90a76422025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091286
application number: ANDA091286
ndc (package): 81033-123-44
ndc (product): 81033-123
ndc11 (package): 81033012344

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283523Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f2ba3d6-6086-eaf2-e063-6294a90a7642Available on FDA.report

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 formatDescriptionMarketing startSampleExclude flagStatus
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