FDA.reportPublic FDA data

NDC 70518-2912-01 - 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
70518-2912
Requested NDC
70518-2912-01
Package NDCs from labels
70518-2912-1, 70518-2912-0, 70518-2912-3, 70518-2912-2, 70518-2912-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-13These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
2023-03-13These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
2023-01-30These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
2023-01-30These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2912-0Gabapentin100 in 1 BOXTABLET1009
70518-2912-1Gabapentin1 in 1 POUCHTABLET19
70518-2912-2Gabapentin100 in 1 BOXTABLET1009
70518-2912-3Gabapentin1 in 1 POUCHTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2912GABAPENTIN TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 4 package rows20250406_bc525ae4-9843-4038-a1b7-0d3543e2282c.zip

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 12 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINRising Pharma Holdings, Inc.969cccfc-e56a-49da-9d36-47c0c3fad7f82025-06-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINPAI Holdings, LLC dba PAI Pharma6d3fd1f9-c831-4262-af10-291838a535412025-05-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINRising Pharma Holdings, Inc.8215da86-d7af-4980-b6d6-4bd46f6bfeaf2025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINATLANTIC BIOLOGICALS CORP.5969f1a8-d6d5-4967-add5-4e2492354d7b2025-05-27Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.0ce53f62-1738-43f4-9a2e-c5dc42a91d092025-05-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINAmneal Pharmaceuticals LLC772d9e7a-3811-455a-99e6-f2a3d0769b9b2025-05-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAurobindo Pharma Limited1a619a14-0b63-4cba-80e7-474c9a1c90b92025-05-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAurobindo Pharma Limited25cf6c40-a239-4dd0-9cad-28da84d285db2025-05-09Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP3c8dca11-78ab-45c1-8bb2-89a41ea5dfa92025-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rx30a2ed14-dcda-f972-e063-6294a90a417c2025-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA206402
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINMcKesson Corporation dba Sky Packaging23eb133e-2f74-4219-9892-0a8e770ec0322025-04-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINMylan Pharmaceuticals Inc.cff7de45-148b-4e96-88fd-6052bf75b5f72025-04-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC3ad96553-73a4-4a9b-8a89-10a29b794ed32025-04-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINProficient Rx LP7fcce531-bf7c-43b6-bea9-8f0602842c532025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCoupler LLC3133c863-d33b-c9d7-e063-6294a90ae8982025-03-25Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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