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 16 of 130 · 2,582 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Pharmadel LLC	4c113bb9-814f-d92d-e063-6294a90a8302	2026-03-30	Warnings	Exact identifier unii: PDC6A3C0OX
Moisture Oyster	GLYCERIN	Moisture Oyster Inc	4e45317a-437f-4d88-e063-6294a90a98d0	2026-03-30	Warnings	Exact identifier unii: PDC6A3C0OX
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Amneal Pharmaceuticals NY LLC	0eb24333-3c11-41dd-888d-3a30d3c9d188	2026-03-30	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Aveeno Skin Relief Healing	GLYCERIN	Kenvue Brands LLC	345fdde5-700b-7103-e063-6394a90a0e3e	2026-03-27	Warnings	Exact identifier unii: PDC6A3C0OX
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	4e0bd355-99c6-8cf4-e063-6294a90ab4b3	2026-03-27	Warnings	Exact identifier unii: 15FIX9V2JP
Crocodile Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Crocodile Tears LLC	4df29336-ea0c-0484-e063-6294a90a685a	2026-03-26	Warnings	Exact identifier unii: PDC6A3C0OX unii: 3NXW29V3WO
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Classic Cosmetics LLC	4df3b8c0-71bc-acdd-e063-6394a90a35c0	2026-03-26	Warnings	Exact identifier unii: 15FIX9V2JP
RYTARY	CARBIDOPA AND LEVODOPA	Amneal Pharmaceuticals LLC	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	2026-03-26	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Silkscreen Sheer Tint Mineral Light-Medium	TITANIUM DIOXIDE, ZINC OXIDE	Curology	4ddbe349-6880-a5fc-e063-6294a90a275c	2026-03-25	Warnings	Exact identifier unii: 15FIX9V2JP
Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	KC Pharmaceuticals, Inc	4de5c844-85ca-ff9f-e063-6394a90ac12c	2026-03-25	Warnings	Exact identifier unii: PDC6A3C0OX unii: 3NXW29V3WO
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4e0450ca-147a-91d7-e063-6394a90ae73b	2026-03-25	Warnings	Exact identifier unii: 15FIX9V2JP
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier unii: PDC6A3C0OX
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd05620-30a3-9cea-e063-6294a90af18b	2026-03-24	Warnings	Exact identifier unii: 15FIX9V2JP
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd1b722-4448-9675-e063-6294a90a5f4f	2026-03-24	Warnings	Exact identifier unii: 15FIX9V2JP
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN	ZINC OXIDE	ENS KOREA Co., Ltd.	34f9688d-efa1-1d3f-e063-6294a90ab127	2026-03-23	Warnings	Exact identifier unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50	SUN SCREEN	Guangdong Bisutang Biotechnology Co., LTD	4dade579-ce77-eea5-e063-6394a90ad46a	2026-03-23	Warnings	Exact identifier unii: 15FIX9V2JP
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZER	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	4a1ec566-549f-45f2-a43d-dacfc7263361	2026-03-20	Warnings	Exact identifier unii: 15FIX9V2JP
Carbidopa, Levodopa, and Entacapone	CARBIDOPA, LEVODOPA, AND ENTACAPONE	Sandoz Inc	9c16c0e0-3b97-486b-b7d5-579f5853e2c5	2026-03-19	Warnings, Adverse reactions	Exact identifier application number: NDA021485 unii: MNX7R8C5VO unii: 4975G9NM6T unii: 46627O600J
Duopa	CARBIDOPA AND LEVODOPA	AbbVie Inc.	7066d371-dc6a-0d6f-7bed-e5dd4ee912da	2026-03-19	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Safecor Health, LLC	015bc056-ee86-4006-ae7c-689b95e566f4	2026-03-19	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.