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 13 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC3133fc78-dd7a-880c-e063-6394a90a89e12025-03-25Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINPrecision Dose, Inc.86c93d8b-6286-44e2-93dd-f1b10a5d83da2025-03-10Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP87b9171b-7d00-40fa-87ff-a717740efe8a2025-03-02Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP64a65366-8577-48f2-9f8e-0332f126d3c12025-03-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.200b61d7-6e4c-923d-e063-6294a90a42cf2025-02-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012025-02-20Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.febf610e-e088-4797-e053-6294a90a3eb52025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.07871ab8-254b-e3c2-e063-6294a90a29ab2025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.0919fed8-e968-b5ac-e063-6294a90afbff2025-02-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepacka1ff94a9-69c4-486a-aab2-563c7ed244c82025-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA206402
rxcui: 310433
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCoupler LLC2cdbb381-88a2-5c5a-e063-6294a90a3e1e2025-01-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.2c65253d-ca49-70eb-e063-6394a90a3cd22025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rxe90d2e3d-ec86-7d1d-e053-2995a90a91672025-01-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rxed9cb5fe-7a2e-e0bc-e053-2a95a90a44702025-01-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rxf40a4ee4-ae8e-769c-e053-2a95a90a344e2025-01-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINDirectrxd5c9dd2c-b8ee-1406-e053-2995a90a02872025-01-21Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.db57e37f-0a78-4c14-8768-a28bbf9fa0da2025-01-21Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINDIRECT RXa5b47f89-ed35-31de-e053-2a95a90a55542025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINClinical Solutions Wholesale, LLC743faa18-5e7c-4fcc-9781-4157450d90c42025-01-16Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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