FDA.reportPublic FDA data

NDC 70518-3176-1 - 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
70518-3176
Requested NDC
70518-3176-1
Package NDCs from labels
70518-3176-1, 70518-3176-0
Manufacturer
REMEDYREPACK INC.
Effective date
2023-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyREMEDYREPACK INC.2023-03-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3176-02023-03-20C16284748780-1f386c64a-14b3-0266-e053-dadaa90a7c1aCarbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only
70518-3176-02023-01-30C16284748780-1f386c64a-14b3-0266-e053-dadaa90a7c1aCarbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only

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
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack34f75728-b9e8-48e7-e063-6394a90afc312025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078986
rxcui: 200131
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC33ed4e35-8be2-d0ea-e063-6394a90a06a62025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 388311
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC33edb22f-f357-ec0f-e063-6394a90a7bc32025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200133
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Limiteda742c03d-10b1-48e2-8df1-48967395ae062025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC2d936849-9c80-5b7f-e063-6294a90aaa6c2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200131
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackebcffad6-da03-43f4-a75b-7de13e94bb7d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUpsher-Smith Laboratories, LLC282c954f-e34a-4bd5-b5eb-771e3c56936f2023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
065aa3c3-a07e-3540-e063-6394a90a5ca523394995-a161-43ac-84b6-d14914cac6a82023-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 23394995-a161-43ac-84b6-d14914cac6a8
CARBAMAZEPINECARBAMAZEPINEProficient Rx LPbf61798e-c07e-4959-909a-2b4c2c83b5322019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLCc1fc31ef-6b2e-4de4-a185-ec44e94e7b402016-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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