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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEAlembic Pharmaceuticals Limited1fc170d7-db1a-486d-8c10-faa6e3da3b1e2025-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack34f75728-b9e8-48e7-e063-6394a90afc312025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC33ed4e35-8be2-d0ea-e063-6394a90a06a62025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC33edb22f-f357-ec0f-e063-6394a90a7bc32025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Limiteda742c03d-10b1-48e2-8df1-48967395ae062025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler, LLC30b75584-3a1c-c125-e063-6294a90acaa72025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAtlantic Biologicals Corps25939406-a836-43cd-9301-56808e9b31ec2025-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEA-S Medication Solutions047bc284-060a-4db9-bf37-75d10f95a0a62025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC2d936849-9c80-5b7f-e063-6294a90aaa6c2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackebcffad6-da03-43f4-a75b-7de13e94bb7d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEChartwell RX, LLC8d5ace90-983b-48c4-baf1-b44f6af146de2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLC697f3e5a-c84b-44a6-b9f3-15e7d9bb63952024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUpsher-Smith Laboratories, LLC282c954f-e34a-4bd5-b5eb-771e3c56936f2023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEProficient Rx LPbf61798e-c07e-4959-909a-2b4c2c83b5322019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLCc1fc31ef-6b2e-4de4-a185-ec44e94e7b402016-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
rxcui: 308979
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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