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 111 of 129 · 2,566 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	83725be5-4a0a-4717-a034-ff2999dd4099	2023-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier unii: PDC6A3C0OX
ERBORIAN - BB CREME NUDE SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	337a771e-c965-421a-a8e7-d853ffe51c2c	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
GenTeal Tears (Moderate)	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	Alcon Laboratories, Inc.	a2992597-3490-6a5c-be45-2b6fa15e1547	2023-12-15	Warnings	Exact identifier unii: PDC6A3C0OX unii: 3NXW29V3WO
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	b4cef09a-f0e4-4054-a200-667df7d150bf	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	5742da4b-6713-4de9-8ab8-b2bf2983371a	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Laura Mercier Flawless Skin Daily Face Shield SPF 40	OCTINOXATE, TITANIUM DIOXIDE	Gurwitch Products, LLC	f86729cd-682f-47b2-9bfa-1113721bfec0	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB SPF 27 PA	TITANIUM DIOXIDE	Boscia LLC	5dc86c0b-c340-4643-a174-a6b4c0826ca9	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	82a23aab-404f-46bb-afaa-8ba9b9bdbefd	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	5f5fb9f5-00be-420a-b19a-b753c45f9a88	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03	TITANIUM DIOXIDE	3LAB, Inc.	8a42a9d8-b9c6-45fb-8264-15f36e2765f0	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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