FDA.reportPublic FDA data

NDC 70518-3146-01 - CARBAMAZEPINE

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
70518-3146
Requested NDC
70518-3146-01
Package NDCs from labels
70518-3146-1, 70518-3146-0, 70518-3146-2, 70518-3146-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CARBAMAZEPINE - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3146-0CARBAMAZEPINE100 in 1 BOXTABLET1009
70518-3146-1CARBAMAZEPINE1 in 1 POUCHTABLET19
70518-3146-2CARBAMAZEPINE30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3146CARBAMAZEPINE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250424_52cf3ba9-0a7c-4809-830e-af93d1532726.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3146-0EA - Each70518-314668cc9f8e-df1e-49e0-a930-3e8a772fd2df12026-01-08
70518-3146-1EA - Each70518-3146aaf6b1af-d00c-424f-a0fc-e1c8f36f22e812026-01-08

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.cd8b51f4-8427-4b18-9d2c-10771d2a65802026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEA-S Medication Solutions1dc2a4d3-2ebc-4c9b-a347-92acd9f231f22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAjanta Pharma USA Inc.2e3c4854-89a1-4e3f-88d4-e164829585fb2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackd3cd36c4-b25e-4716-be1d-0b2c83ea6a032026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
Carbamazepine ERCARBAMAZEPINEOryza Pharmaceuticals Inc.34b375d0-68b0-4bd5-8ac9-be043b57e91c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack62d38b93-7dd0-48e7-bd59-a434d52520f62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEMajor Pharmaceuticals2676f950-48b4-4bef-a792-ea4570de9aa62026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINE ERCARBAMAZEPINEBostal LLCb48741b3-0889-47b8-a26e-b12614f6e7fc2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINENuCare Pharmaceuticals, Inc.509bd024-9944-a2f3-e063-6394a90ae4cb2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECardinal Health 107, LLC232ef732-ee6d-4ac7-8e78-c619b611fbbe2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.20cd4276-afb1-43e5-abb3-e2af7f8a71dd2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.3207764f-0663-477e-ad1f-f5fb43b6bbf32026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEANI Pharmaceuticals, Inc.c1876184-0323-4b06-b459-603b40c0c0022026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepackc72a0668-7cd7-46a8-86d1-d3c17c4b900f2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack34f57a68-57ad-57f1-e063-6394a90a3d332026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEPreferred Pharmaceuticals Inc.867a5f4d-8ae6-4339-bbb4-0bf62fb082e52026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals Inc.32dc301e-881d-47b0-ad16-f9ff31d193242026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINENorthstar Rx LLCb563e4a1-d7dd-4901-ad45-614f856875892026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEGolden State Medical Supply, Inc.536811ab-308b-4866-9185-9e41494835122026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEGolden State Medical Supply, Inc.1922a7cd-6a43-dab5-e063-6294a90a3d8f2026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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