FDA.reportPublic FDA data

NDC 70518-3266-1 - Tegretol XR

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
70518-3266
Requested NDC
70518-3266-1
Package NDCs from labels
70518-3266-1, 70518-3266-0
Manufacturer
REMEDYREPACK INC.
Effective date
2023-10-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TegretolREMEDYREPACK INC.2023-10-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3266-02023-03-23C16284748780-1f386c64a-3e67-0266-e053-dadaa90a7c1aTegretol
70518-3266-02023-01-30C16284748780-1f386c64a-3e67-0266-e053-dadaa90a7c1aTegretol

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 · 95 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
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
carbamazepineCARBAMAZEPINENorthstar Rx LLCc91a5a1b-5481-445b-86e8-f10109ac39372026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAscend Laboratories, LLCf0a254c5-bd33-4b14-b9f0-830b3438f5c62026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
TegretolCARBAMAZEPINENovartis Pharmaceuticals Corporation8d409411-aa9f-4f3a-a52c-fbcb0c3ec0532026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020234
ndc (product): 0078-0512
rxcui: 866307
rxcui: 308972
rxcui: 308979
rxcui: 402506
rxcui: 402505
rxcui: 308976
rxcui: 308971
rxcui: 866305
rxcui: 199378
rxcui: 866303
spl id: ac037b7c-7ff9-415e-9870-963f9bbf79a7
spl set id: 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053
unii: 33CM23913M
CarbatrolCARBAMAZEPINETakeda Pharmaceuticals America, Inc.bc03e499-5bac-4293-bff4-6864153a624d2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUnichem Pharmaceuticals (USA), Inc.50ba2042-fc67-4266-a773-a30f07649a5a2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.48080efd-1781-4585-83f8-c43957ac63b32026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Inc.87d343a8-84d5-4cdd-b0a0-629311b51f112026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
carbamazepineCARBAMAZEPINEZydus Lifesciences Limitedd10e5f83-56db-4bc9-8c51-150a2e3e20ea2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
carbamazepineCARBAMAZEPINEZydus Pharmaceuticals (USA) Inc.c5e4a25a-0137-4327-96f5-15735891ad5c2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
CarbamazepineCARBAMAZEPINETorrent Pharmaceuticals Limited7c4860c1-daba-4e0f-97fd-d30cbc8603a22026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEAmerican Health Packaging7108d630-89bc-4815-b6fb-a1f4676c496e2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEBionpharma Inc.,138d9ed1-2f8e-d19d-e063-6394a90a695d2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.cd8b51f4-8427-4b18-9d2c-10771d2a65802026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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