FDA.reportPublic FDA data

NDC 48433-015-01 - Carbidopa and Levodopa

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
48433-015
Requested NDC
48433-015-01
Package NDCs from labels
48433-015-01, 48433-015-20
Manufacturer
Safecor Health, LLC
Effective date
2026-03-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbidopa and Levodopa - Safecor Health, LLCSafecor Health, LLC2026-03-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-015-01Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
48433-015-20Carbidopa and Levodopa100 in 1 CARTONTABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-015-20EA - Each48433-015f274ea04-d515-40a2-9be0-af60ca97fec812026-05-22

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 2 of 5 · 100 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Pharmaceuticals Inc.aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a2026-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA075091
ndc (product): 0378-0094
ndc (product): 0378-0088
rxcui: 308988
rxcui: 308989
spl id: 164375a9-db50-4cb3-86ca-a52a3e74cc83
spl set id: aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.b29e58f0-67b1-4036-a4a8-4915a8c13cdf2026-04-24Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.beedd327-bbc5-4f17-838a-4e72bf0867f02026-04-24Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.57688b2c-7be0-4e73-9b4f-7ec3b5dc1c372026-04-24Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.9ac804f1-7e15-48bc-8ae9-25181a629dd42026-04-24Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACoupler LLC500f0cdb-10e1-9545-e063-6394a90a3ad12026-04-22Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACardinal Health 107, LLC19d853e2-b8bd-490e-b8d2-b38bec68a1392026-04-16Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAurobindo Pharma Limited4ced8a05-27ac-463f-b331-387e473fdaa12026-04-09Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONERising Pharma Holdings, Inc.2f8e82d7-6baf-456a-b8c3-4fda6e3179022026-04-08Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa, Levodopa and EntacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEMacleods Pharmaceuticals Limitedf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2026-04-08Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAXLCare Pharmaceuticals, Inc.0c630a24-dc51-4601-a5d6-2f9e397a04492026-04-03Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACamber Pharmaceuticals, Inc.770ba054-fec4-4833-8096-85c3ce3ae8302026-04-01Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
carbidopa, levodopa and entacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEAlembic Pharmaceuticals Inc.9d4e886e-edec-471d-b619-bf4828a6b7ce2026-03-31Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAlembic Pharmaceuticals Inc.ac18e5fa-e2ee-4aa5-8d0f-94b63a076e662026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 308988
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals NY LLC0eb24333-3c11-41dd-888d-3a30d3c9d1882026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 308988
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
RYTARYCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals LLC6c1f7cd4-de56-45c1-a734-5e77b4aeb6f72026-03-26Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa, Levodopa, and EntacaponeCARBIDOPA, LEVODOPA, AND ENTACAPONESandoz Inc9c16c0e0-3b97-486b-b7d5-579f5853e2c52026-03-19Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
DuopaCARBIDOPA AND LEVODOPAAbbVie Inc.7066d371-dc6a-0d6f-7bed-e5dd4ee912da2026-03-19Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPASafecor Health, LLC015bc056-ee86-4006-ae7c-689b95e566f42026-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA075091
ndc (package): 48433-016-20
ndc (package): 48433-015-20
ndc (package): 48433-015-01
ndc (package): 48433-016-01
ndc (product): 48433-015
ndc (product): 48433-016
ndc11 (package): 48433001501
rxcui: 308988
rxcui: 308989
spl id: 4d642d35-3931-745e-e063-6294a90a8e63
spl set id: 015bc056-ee86-4006-ae7c-689b95e566f4
unii: MNX7R8C5VO
unii: 46627O600J
carbidopa, levodopa and entacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEAlembic Pharmaceuticals Limited9ff83838-b7d0-4eec-98f2-fcc85789a1892026-02-17Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J

Reported adverse events (FAERS/openFDA)#

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