FDA.reportPublic FDA data

NDC 70518-3146-1 - 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
70518-3146
Requested NDC
70518-3146-1
Package NDCs from labels
70518-3146-1, 70518-3146-0, 70518-3146-2
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-28
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.2026-09-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3146-0CARBAMAZEPINE100 in 1 BOXTABLET1009
70518-3146-1CARBAMAZEPINE1 in 1 POUCHTABLET19
70518-3146-2CARBAMAZEPINE30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3146CARBAMAZEPINE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250424_52cf3ba9-0a7c-4809-830e-af93d1532726.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3146-0EA - Each70518-314668cc9f8e-df1e-49e0-a930-3e8a772fd2df12026-01-08
70518-3146-1EA - Each70518-3146aaf6b1af-d00c-424f-a0fc-e1c8f36f22e812026-01-08

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 · 82 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
unii: 33CM23913M
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
ndc (product): 60505-0183
rxcui: 308979
spl id: 8a415613-aacb-217a-cf82-67ed8f5e7ceb
spl set id: bf0d012f-da14-8ce3-d74f-56172cddebc5
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
rxcui: 308979
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
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
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.52cf3ba9-0a7c-4809-830e-af93d15327262026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075948
ndc (package): 70518-3146-0
ndc (package): 70518-3146-1
ndc (package): 70518-3146-2
ndc (product): 70518-3146
ndc11 (package): 70518314601
rxcui: 308979
spl id: 583ae88f-f2fd-d821-e063-6294a90a7b95
spl set id: 52cf3ba9-0a7c-4809-830e-af93d1532726
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
rxcui: 308979
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308979
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.