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 101 of 129 · 2,566 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proceuticals Private Label by TiZO tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1e78109f-4d2e-2705-e063-6294a90a5ad3	2024-07-30	Warnings	Exact identifier unii: 15FIX9V2JP
Replenix Sheer SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4	2024-07-29	Warnings	Exact identifier unii: 15FIX9V2JP
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals,Inc.	ad2ab0c4-188b-f025-e053-2a95a90a2816	2024-07-17	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
Derma E Sun Defense Face SPF 30	ZINC OXIDE TITANIUM DIOXIDE	derma e	d90b8f81-de7a-4022-800a-90f063e94180	2024-07-17	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1d611494-648b-6e5f-e063-6294a90a4500	2024-07-16	Warnings	Exact identifier unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8df98d97-a5d2-4d52-8bd2-130a13501d60	2024-07-16	Warnings	Exact identifier unii: 15FIX9V2JP
Derma E Sun Defense SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	derma e	395b73a4-dae7-49da-9dab-ab622117c8c0	2024-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1ce8c1da-565d-5487-e063-6294a90a1bde	2024-07-10	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1cc19337-cf54-af5d-e063-6394a90a1ceb	2024-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Zenibell Snail IntensiveCream	GLYCERIN	MISOCOS	97c19dca-237c-c968-e053-2a95a90aeae7	2024-07-05	Warnings	Exact identifier unii: PDC6A3C0OX
Zenibell Snail Intensive Toner	GLYCERIN	MISOCOS	97c1b556-824d-bef7-e053-2a95a90ae1f2	2024-07-05	Warnings	Exact identifier unii: PDC6A3C0OX
aewajin Derma Hydrocell	GLYCERIN	MISOCOS	980fcaea-27ba-da49-e053-2995a90ad506	2024-07-05	Warnings	Exact identifier unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold Serum	GLYCERIN	MISOCOS	a17b2c6e-9db8-bae4-e053-2a95a90adcf6	2024-07-05	Warnings	Exact identifier unii: PDC6A3C0OX
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier unii: PDC6A3C0OX
Zenibell Snail Intensive	GLYCERIN	MISOCOS	97747267-26f1-d06f-e053-2a95a90ab087	2024-07-04	Warnings	Exact identifier unii: PDC6A3C0OX
Exel Clarifying Line SPF 50	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE	Exelencia importers	0d6d4098-4121-477e-b404-3ab18628ed68	2024-06-30	Warnings	Exact identifier unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	28c51c59-dbfb-45e5-b536-6e5d5c5560d6	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	84831a49-02d8-421e-8f05-f1358d7149cb	2024-06-28	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	f6457973-3718-44cd-a764-de0b089d4eee	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	8598d56b-adcd-48e8-b6fc-77bc934009c7	2024-06-27	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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