FDA.reportPublic FDA data

NDC 68084-444-11 - 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
68084-444
Requested NDC
68084-444-11
Package NDCs from labels
68084-444-11, 68084-444-01
Manufacturer
American Health Packaging
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbamazepine - American Health PackagingAmerican Health Packaging2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-444-01Carbamazepine100 in 1 BOX, UNIT-DOSETABLET1007
68084-444-11Carbamazepine1 in 1 BLISTER PACKTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-444CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241025_1dd3d934-efee-4fdb-ae6f-f47b61831a2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-444-01EA - Each68084-4443386f80e-91ad-44d9-9031-7cb0e366fcd712014-07-02
68084-444-11EA - Each68084-444eec407d9-2650-420b-ad1f-a4d86eeb4efb12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]2

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
rxcui: 308979
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
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEMajor Pharmaceuticals2676f950-48b4-4bef-a792-ea4570de9aa62026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECardinal Health 107, LLC232ef732-ee6d-4ac7-8e78-c619b611fbbe2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
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
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
application number: ANDA075948
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEPreferred Pharmaceuticals Inc.867a5f4d-8ae6-4339-bbb4-0bf62fb082e52026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals Inc.32dc301e-881d-47b0-ad16-f9ff31d193242026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
rxcui: 308979
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
rxcui: 308979
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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