FDA.reportPublic FDA data

NDC 60505-2807-07 - 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
60505-2807
Requested NDC
60505-2807-07
Package NDCs from labels
60505-2807-3, 60505-2807-7, 60505-2807-5, 60505-2807-07
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-14
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.2026-09-14HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-10HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - AvPAKAvPAK2026-01-08HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-11-14HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-11-05HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-07-28HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2807-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2807-5Carbamazepine500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50015
60505-2807-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2807CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20240922_e91f9de3-3fdd-0a6b-71ce-53a2cc142816.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2807-7EA - Each60505-2807a6b4821f-c96f-40ae-b7fe-392e23db7d0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]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 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEA-S Medication Solutions1dc2a4d3-2ebc-4c9b-a347-92acd9f231f22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEMajor Pharmaceuticals2676f950-48b4-4bef-a792-ea4570de9aa62026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078986
rxcui: 200133
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
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECardinal Health 107, LLC232ef732-ee6d-4ac7-8e78-c619b611fbbe2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 200131
rxcui: 388311
rxcui: 200133
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
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEPreferred Pharmaceuticals Inc.867a5f4d-8ae6-4339-bbb4-0bf62fb082e52026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals Inc.32dc301e-881d-47b0-ad16-f9ff31d193242026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
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
CarbamazepineCARBAMAZEPINEGolden State Medical Supply, Inc.8a1ce79d-18ea-f30b-e053-2995a90ad1fb2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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