FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Gabapentin - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2025-05-13HUMAN PRESCRIPTION DRUG LABEL
Gabapentin - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2023-04-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-698-902024-04-02C16284748780-11030e365-49e8-111a-e063-dadaa90a10e2These 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
65162-698-902024-01-30C16284748780-11030e365-49e8-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
65162-698-39Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION528
65162-698-54Gabapentin50 in 1 CARTONSOLUTION5028
65162-698-90Gabapentin473 mL in 1 BOTTLESOLUTION47328

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-698GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS LLC]27Current NDC, Legacy NDC, 3 package rows20241006_772d9e7a-3811-455a-99e6-f2a3d0769b9b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-698-90ML - Milliliter65162-698781d1576-35f2-4340-9bb7-8435d1507cd512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGABAPENTIN 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 1 of 27 · 526 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932026-09-11Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINClinical Solutions Wholesale, LLCb7f9a106-52c6-49e4-acf5-8fb07761ba4f2026-09-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef2026-09-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2026-09-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-08-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
GabapentinGABAPENTINREMEDYREPACK INC.4615aaa7-73d4-4473-8f26-e7a982f8a1662026-08-27Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack4c22c3e6-2471-4b89-945b-f846c4d7884e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-08-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-08-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackf0e7a6c9-ae6c-4259-81ab-a37db54e3c802026-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINNuCare Pharmaceuticals, Inc.596eb696-7696-202e-e063-6394a90a28442026-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackeb2f6784-e7be-41b6-871b-2c3c961664ab2026-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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