NDC 64679-784-02 - CARBIDOPA, LEVODOPA AND ENTACAPONE

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: 64679-784
Requested NDC: 64679-784-02
Package NDCs from labels: 64679-784-04, 64679-784-02
Manufacturer: Wockhardt USA LLC. | Orion Corporation, Orion Pharma
Effective date: 2020-12-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LEVODOPA - Wockhardt USA LLC. \| Orion Corporation, Orion Pharma	Wockhardt USA LLC. \| Orion Corporation, Orion Pharma	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64679-784-04	2020-02-21	C162847	48780-1	9d75b9d0-bc89-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003
64679-784-04	2020-01-31	C162847	48780-1	9d75b9d0-bc89-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-784-02	EA - Each	64679-784	9acd207e-2521-481c-b60a-5b616c517c22	1	2013-02-13
64679-784-04	EA - Each	64679-784	f541a5e7-2468-4030-b17b-65339d116c9c	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
ENTACAPONE	ACTIVE INGREDIENT	4975G9NM6T	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
ENTACAPONE	ACTIVE MOIETY	4975G9NM6T	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]	4

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 3 of 131 · 2,612 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINEMET	CARBIDOPA AND LEVODOPA	Organon LLC	9b17b028-964a-473c-823d-81423535bd66	2026-08-01	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Continuous Correction Cream	TITANIUM DIOXIDE	Baxter of California, LLC	1cbcc648-f2e1-af60-e063-6294a90ad4bb	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Topwin Speedy Enema	GLYCERIN	Health Chemical Pharmaceutical Co., Ltd	3ba8c3d2-1780-42e1-bec5-8f98771d475e	2026-07-27	Warnings	Exact identifier unii: PDC6A3C0OX
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier unii: 15FIX9V2JP
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: PDC6A3C0OX unii: 6OZP39ZG8H
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS	POLYVINYL ALCOHOL, POVIDONE	AmerisourceBergen	ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f	2026-07-22	Warnings	Exact identifier unii: FZ989GH94E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	571083ce-cd35-a638-e063-6394a90ae4c7	2026-07-20	Warnings	Exact identifier unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Inbrija	LEVODOPA	Merz Pharmaceuticals, LLC	077c0f39-a3a2-4b2b-a184-09131889dcfb	2026-07-20	Warnings, Adverse reactions	Exact identifier unii: 46627O600J
Calamine	FERRIC OXIDE RED	Better Living Brands, LLC	c7ef0ef3-6861-4b94-af4b-371fee8c1f3d	2026-07-16	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	3b06a0e2-bec8-4178-942b-67eb47f2916e	2026-07-16	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	043e58c6-092d-4637-90f1-9d36af143a24	2026-07-16	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	5682a705-de0e-6b70-e063-6394a90aadfb	2026-07-13	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	5644d10f-620e-810e-e063-6294a90af678	2026-07-10	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Teva Pharmaceuticals USA, Inc.	4ace5274-b6cf-414c-b9c0-f60e28a9cea5	2026-07-09	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J

Reported adverse events (FAERS/openFDA)#

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