Gabapentin

Product NDC: 65162-698
11-digit product format: 651620698
Labeler code: 65162
Product ID: 65162-698_bcc054b1-a2fa-40b7-b150-b937763fcf7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA202024
Marketing category: ANDA
Marketing start: 2011-09-30
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#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	250 mg/5mL

Field, Values table
Field	Values
Unii	6CW7F3G59X
Rxcui	283523

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-698-90	2024-04-02	C162847	48780-1	1030e365-49e8-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
65162-698-90	2024-01-30	C162847	48780-1	1030e365-49e8-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-698-39	Gabapentin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	28
65162-698-54	Gabapentin	50 in 1 CARTON	SOLUTION	50	28
65162-698-90	Gabapentin	473 mL in 1 BOTTLE	SOLUTION	473	28

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-698-90	ML - Milliliter	65162-698	781d1576-35f2-4340-9bb7-8435d1507cd5	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-698	GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS LLC]	27	Current NDC, Legacy NDC, 3 package rows	20241006_772d9e7a-3811-455a-99e6-f2a3d0769b9b.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283523	gabapentin 250 MG in 5 mL Oral Solution	PSN	772d9e7a-3811-455a-99e6-f2a3d0769b9b	28
283523	gabapentin 50 MG/ML Oral Solution	SCD	772d9e7a-3811-455a-99e6-f2a3d0769b9b	28
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	772d9e7a-3811-455a-99e6-f2a3d0769b9b	28
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	772d9e7a-3811-455a-99e6-f2a3d0769b9b	28
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	772d9e7a-3811-455a-99e6-f2a3d0769b9b	28
283523	gabapentin 250 MG in 5 mL Oral Solution	PSN	18cc4e21-8989-43c9-943f-4583b2fe92d3	3
283523	gabapentin 50 MG/ML Oral Solution	SCD	18cc4e21-8989-43c9-943f-4583b2fe92d3	3
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	18cc4e21-8989-43c9-943f-4583b2fe92d3	3
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	18cc4e21-8989-43c9-943f-4583b2fe92d3	3
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	18cc4e21-8989-43c9-943f-4583b2fe92d3	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-698-39	65162069839	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
65162-698-54	65162069854	50 CUP, UNIT-DOSE in 1 CARTON (65162-698-54) / 5 mL in 1 CUP, UNIT-DOSE (65162-698-39)		2011-09-30		No	No	Historical
65162-698-90	65162069890	473 mL in 1 BOTTLE (65162-698-90)	473 ml	2011-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2025-05-13	HUMAN PRESCRIPTION DRUG LABEL	28
Gabapentin	ATLANTIC BIOLOGICALS CORP.	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL	3