Gabapentin

Product NDC: 81033-124
11-digit product format: 810330124
Labeler code: 81033
Product ID: 81033-124_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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091286-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2016-03-14

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2016-03-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A091286-001	AA	1	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Ajenat Pharmaceuticals LLC	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286
Gabapentin	GABAPENTIN	JVET PHARMACEUTICALS LLC	63a5fc6d-ca57-4726-b70d-805ac023d959	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	4470a567-93a6-a293-e063-6394a90affc1	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	3f2ba3d6-6086-eaf2-e063-6294a90a7642	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286 ndc (product): 81033-124

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f2ba3d6-6086-eaf2-e063-6294a90a7642	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81033-124-06	Gabapentin	6 mL in 1 CUP, UNIT-DOSE	SOLUTION	6		1
81033-124-44	Gabapentin	40 in 1 CARTON	SOLUTION	40		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-124-06	ML - Milliliter	81033-124	dac763c1-c481-43a1-86d4-7d259050a2c0	1	2025-10-14
81033-124-44	ML - Milliliter	81033-124	55a1fe8c-d9ba-4f1c-9663-d8638e8de22d	1	2025-10-14

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283523	gabapentin 250 MG in 5 mL Oral Solution	PSN	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 50 MG/ML Oral Solution	SCD	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-124-06	81033012406	6 mL in 1 CUP, UNIT-DOSE	6 ml				Historical
81033-124-44	81033012444	40 CUP, UNIT-DOSE in 1 CARTON (81033-124-44) / 6 mL in 1 CUP, UNIT-DOSE (81033-124-06)		2025-09-01	No	No	Current