FDA.reportPublic FDA data

NDC 60505-2805-07 - 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
60505-2805
Requested NDC
60505-2805-07
Package NDCs from labels
60505-2805-3, 60505-2805-7, 60505-2805-8, 60505-2805-07
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-10
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 onlyApotex Corp. | Apotex Inc.2026-09-10HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2026-02-12HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - AvPAKAvPAK2026-01-08HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-10-30HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2024-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2805-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2805-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015
60505-2805-8Carbamazepine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2805CARBAMAZEPINE 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
60505-2805-7EA - Each60505-2805a240e407-2f26-47eb-a74b-56925f8122d512012-07-24

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 1 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEApotex Corp.e91f9de3-3fdd-0a6b-71ce-53a2cc1428162026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078986
ndc (package): 60505-2805-7
ndc (package): 60505-2807-3
ndc (package): 60505-2807-5
ndc (package): 60505-2807-7
ndc (package): 60505-2806-7
ndc (package): 60505-2805-8
ndc (package): 60505-2806-3
ndc (package): 60505-2806-8
ndc (package): 60505-2805-3
ndc (product): 60505-2807
ndc (product): 60505-2805
ndc (product): 60505-2806
ndc11 (package): 60505280507
rxcui: 200131
rxcui: 388311
rxcui: 200133
spl id: c24e1663-4df1-d5a1-f9ed-551ba3552575
spl set id: e91f9de3-3fdd-0a6b-71ce-53a2cc142816
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
carbamazepineCARBAMAZEPINENorthstar Rx LLCc91a5a1b-5481-445b-86e8-f10109ac39372026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAmerican Health Packaging87b87b57-021a-4cb2-9edd-6efa732c208f2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAscend Laboratories, LLCf0a254c5-bd33-4b14-b9f0-830b3438f5c62026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
TegretolCARBAMAZEPINENovartis Pharmaceuticals Corporation8d409411-aa9f-4f3a-a52c-fbcb0c3ec0532026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbatrolCARBAMAZEPINETakeda Pharmaceuticals America, Inc.bc03e499-5bac-4293-bff4-6864153a624d2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200131
rxcui: 388311
rxcui: 200133
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUnichem Pharmaceuticals (USA), Inc.50ba2042-fc67-4266-a773-a30f07649a5a2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.48080efd-1781-4585-83f8-c43957ac63b32026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Inc.87d343a8-84d5-4cdd-b0a0-629311b51f112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.52cf3ba9-0a7c-4809-830e-af93d15327262026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
carbamazepineCARBAMAZEPINEZydus Lifesciences Limitedd10e5f83-56db-4bc9-8c51-150a2e3e20ea2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
carbamazepineCARBAMAZEPINEZydus Pharmaceuticals (USA) Inc.c5e4a25a-0137-4327-96f5-15735891ad5c2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINETorrent Pharmaceuticals Limited7c4860c1-daba-4e0f-97fd-d30cbc8603a22026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAmerican Health Packaging7108d630-89bc-4815-b6fb-a1f4676c496e2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9471b7fb-29d3-4009-9d0f-f20c27351db52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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