NDC 65162-698-39 - Gabapentin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 65162-698
Requested NDC: 65162-698-39
Package NDCs from labels: 65162-698-90, 65162-698-39, 65162-698-54
Manufacturer: Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC
Effective date: 2025-05-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

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

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

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

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6670a64f-7f58-479f-b285-394abb753e2e	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Coupler LLC	5954a330-c225-00bd-e063-6294a90a7581	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Trifluent Pharma, LLC	59442de1-7cf0-35f6-e063-6294a90a57d7	2026-08-17	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	691205ba-fa65-4bc9-ba20-7d361382cff9	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	97e47698-97c9-4eb5-a108-5850c2aa2818	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-08-06	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-08-06	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-07-30	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: K679OBS311
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	Warnings, Adverse reactions	Exact identifier unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.