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 89 of 129 · 2,574 matching rows.

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Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	4e15f6ca-a40c-485f-be3f-07c2ed7cb498	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d3bdda65-bcb4-42d9-84af-d14c7f4421bd	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
OASIS Tears Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	d9d71b1d-82a6-42e7-9ef2-2d041daef936	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	d5ffe993-de8f-4623-a010-9cb8dd70de07	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	8b298516-70df-47ab-834f-51dcde28a43a	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	6a14ee23-28c9-4704-8af9-d1c4db0d9256	2024-12-23	Warnings	Exact identifier unii: 15FIX9V2JP
EcoStick Sunscreen SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	Stream2Sea, LLC	eba17b7a-5e96-4462-9b71-44c2bc577dce	2024-12-21	Warnings	Exact identifier unii: 15FIX9V2JP
Planet Protecting Sunscreen 30	TITANIUM DIOXIDE	Stream2Sea, LLC	89e44c5f-121e-4fdd-b9e0-023909ea32f5	2024-12-21	Warnings	Exact identifier unii: 15FIX9V2JP
Face Reality mineral matte spf 28 Sunscreen SPF 28	ZINC OXIDE, TITANIUM DIOXIDE	Face Reality, LLC	29b70afe-cf9d-d0ba-e063-6394a90a1cc4	2024-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Oars and Alps LLC	f3971b85-a13e-4195-e053-2995a90a73cb	2024-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
Carpe SPF 30 Face Primer	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc. DBA Carpe	feac5ee2-faa5-fd17-e053-6394a90a7f99	2024-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Small World Brands	b1df4c81-333b-450d-963e-6670ab9bbda9	2024-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beige	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	062fa0d9-f384-48af-8269-42de3a788db1	2024-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ac9a5-f609-d804-e063-6394a90abd05	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ad424-16a8-66b1-e063-6394a90a0753	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afef9-758f-74e1-e063-6294a90a8072	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3276-7973-d33f-e063-6294a90a6ce1	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afe24-d496-5745-e063-6394a90aa1b3	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b1f9a-34fd-cb50-e063-6394a90af925	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3236-3f3d-c9e8-e063-6394a90a7443	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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