FDA.reportPublic FDA data

NDC 57664-539 - 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
57664-539
Package NDCs from labels
57664-539-88, 57664-539-13, 57664-539-18
Manufacturer
CARACO PHARMACEUTICAL LABORATORIES, LTD.
Effective date
2008-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbamazepine - CARACO PHARMACEUTICAL LABORATORIES, LTD.CARACO PHARMACEUTICAL LABORATORIES, LTD.2008-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-539-13Carbamazepine500 in 1 BOTTLETABLET5003
57664-539-18Carbamazepine1000 in 1 BOTTLETABLET10003
57664-539-88Carbamazepine100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-539CARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]33 package rows20080215_c13bc0b8-7900-4ef4-98ed-e1315a08d95d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbamazepineACTIVE INGREDIENT33CM23913MCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
carbamazepineACTIVE MOIETY33CM23913MCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
colloidal silicon dioxideINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
corn starchINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
FD&C Red #40 aluminum lakeINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
hypromelloseINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
pregelatinized starchINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3
sodium starch glycolateINACTIVE INGREDIENTCARBAMAZEPINE (CARBAMAZEPINE) TABLET CARBAMAZEPINE (CARBAMAZEPINE) TABLET, CHEWABLE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]3

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINEGolden State Medical Supply, Inc.9fca7d59-dd9e-4fd8-bf34-e2f7e5a368012025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEAvPAK41157f3e-61c4-1cbd-e063-6294a90a219f2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack2d2c5317-4072-477b-a4e2-f6765fc716572025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack45b355e6-9c19-4138-a1f8-53508e88f5a92025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Limiteda742c03d-10b1-48e2-8df1-48967395ae062025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEA-S Medication Solutions047bc284-060a-4db9-bf37-75d10f95a0a62025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackebcffad6-da03-43f4-a75b-7de13e94bb7d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLC697f3e5a-c84b-44a6-b9f3-15e7d9bb63952024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEProficient Rx LPbf61798e-c07e-4959-909a-2b4c2c83b5322019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLCc1fc31ef-6b2e-4de4-a185-ec44e94e7b402016-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
D42B1537-3B55-BD87-1561-F9211F3B65FAc13bc0b8-7900-4ef4-98ed-e1315a08d95d2008-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: D42B1537-3B55-BD87-1561-F9211F3B65FA
spl set id: c13bc0b8-7900-4ef4-98ed-e1315a08d95d

Reported adverse events (FAERS/openFDA)#

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