FDA.reportPublic FDA data

NDC 70518-3591-1 - 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
70518-3591
Requested NDC
70518-3591-1
Package NDCs from labels
70518-3591-1, 70518-3591-0
Manufacturer
REMEDYREPACK INC.
Effective date
2024-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CARBAMAZEPINE - REMEDYREPACK INC.REMEDYREPACK INC.2024-01-15HUMAN PRESCRIPTION DRUG LABEL

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 8 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINERising Pharma Holdings, Inc.bf1590a0-68a7-45ed-817e-f97366f96ec42025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211623
ndc (product): 16571-682
rxcui: 402506
rxcui: 402505
rxcui: 199378
spl id: 4444f4ee-dd67-4e98-8cd6-91bf2fb0cb0f
spl set id: bf1590a0-68a7-45ed-817e-f97366f96ec4
unii: 33CM23913M
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
Carbamazepine ERCARBAMAZEPINE ERChartwell RX, LLCbf2bff52-d1ae-4b81-951c-7d39d3c5058f2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
CARBAMAZEPINECARBAMAZEPINEGolden State Medical Supply, Inc.9fca7d59-dd9e-4fd8-bf34-e2f7e5a368012025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackd684dfd8-1e0d-47a1-bf37-ada6413815f22025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack0ccee1ed-3d7c-452b-9519-c1ddb92893df2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
CarbamazepineCARBAMAZEPINEAlembic Pharmaceuticals Inc.726a127b-03b2-44e8-a63d-078b35e275252025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402506
rxcui: 402505
rxcui: 199378
unii: 33CM23913M

Reported adverse events (FAERS/openFDA)#

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