FDA.reportPublic FDA data

NDC 57664-535-88 - 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
57664-535
Requested NDC
57664-535-88
Package NDCs from labels
57664-535-88, 57664-535-13, 57664-535-18
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
57664-535-13Carbamazepine500 in 1 BOTTLETABLET5003
57664-535-18Carbamazepine1000 in 1 BOTTLETABLET10003
57664-535-88Carbamazepine100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-535CARBAMAZEPINE (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 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
TegretolCARBAMAZEPINENovartis Pharmaceuticals Corporation8d409411-aa9f-4f3a-a52c-fbcb0c3ec0532026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEUnichem Pharmaceuticals (USA), Inc.50ba2042-fc67-4266-a773-a30f07649a5a2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
rxcui: 197441
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Inc.87d343a8-84d5-4cdd-b0a0-629311b51f112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.52cf3ba9-0a7c-4809-830e-af93d15327262026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
rxcui: 308973
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9471b7fb-29d3-4009-9d0f-f20c27351db52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308973
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.40bf2923-24b1-4af1-8d20-03cf06b455a52026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEBionpharma Inc.,138d9ed1-2f8e-d19d-e063-6394a90a695d2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308973
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEA-S Medication Solutions1dc2a4d3-2ebc-4c9b-a347-92acd9f231f22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack62d38b93-7dd0-48e7-bd59-a434d52520f62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINENuCare Pharmaceuticals, Inc.509bd024-9944-a2f3-e063-6394a90ae4cb2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CarbamazepineCARBAMAZEPINECardinal Health 107, LLC232ef732-ee6d-4ac7-8e78-c619b611fbbe2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepackc72a0668-7cd7-46a8-86d1-d3c17c4b900f2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308973
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack34f57a68-57ad-57f1-e063-6394a90a3d332026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979

Reported adverse events (FAERS/openFDA)#

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