FDA.reportPublic FDA data

NDC 67046-1559-03 - 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
67046-1559
Requested NDC
67046-1559-03
Package NDCs from labels
67046-1559-3, 67046-1559-03
Manufacturer
Coupler LLC | Nostrum Laboratories, Inc.
Effective date
2025-04-29
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 onlyCoupler LLC | Nostrum Laboratories, Inc.2025-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1559-3Carbamazepine30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1559CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [COUPLER LLC]1Current NDC, 1 package rows20250503_33edb22f-f357-ec0f-e063-6394a90a7bc3.zip

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 112 · 2,237 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
rxcui: 200133
unii: 33CM23913M
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
carbamazepineCARBAMAZEPINENorthstar Rx LLCc91a5a1b-5481-445b-86e8-f10109ac39372026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
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
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
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
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
CarbatrolCARBAMAZEPINETakeda Pharmaceuticals America, Inc.bc03e499-5bac-4293-bff4-6864153a624d2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200133
unii: 33CM23913M
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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