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 97 of 129 · 2,566 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffbb6af-5a04-f58a-e053-2995a90a1ae2	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands, LLC	441a46f0-ecda-4448-e054-00144ff88e88	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffb8219-7076-de64-e053-2a95a90a6036	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cfee02eb-92f9-be12-e053-2a95a90a4337	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Entacapone	ENTACAPONE	NCS HealthCare of KY, LLC dba Vangard Labs	bff19d15-c57b-4a40-bba4-1e0a85fd09c5	2024-10-23	Warnings, Adverse reactions	Exact identifier unii: 4975G9NM6T
CVS Health 60 Plus Sensitive Skin Sun	TITANIUM DIOXIDE, ZINC OXIDE	CVS Pharmacy	477c25ec-33db-04a6-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bali Body Tinted Super Serum Natural SPF 30	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Bali Body Pty Ltd	f5eeaf37-33f2-2c0c-e053-2a95a90abcc0	2024-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f4481bf3-6dc7-5641-e053-2a95a90ad938	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f45d25d2-9305-5858-e053-2a95a90a7f7b	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Bliss GVS Children	GLYCERIN	Bliss GVS Pharma Limited	03237ed2-265f-4acd-b504-d82b9263287c	2024-10-17	Warnings	Exact identifier unii: PDC6A3C0OX
Caladryl	FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE	Bausch Health US, LLC	67d4fd42-9fed-4238-9f5a-c9403abbcf20	2024-10-17	Warnings	Exact identifier unii: 1K09F3G675
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier unii: 15FIX9V2JP
L DOPA 4X	L DOPA	BioActive Nutritional, Inc.	595b2d31-db9e-4eec-984f-92e93b274b3b	2024-10-17	Warnings	Exact identifier unii: 46627O600J
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	f207467e-ac62-446a-b42e-371efd0c7b2b	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	WEGMANS FOOD MARKETS INC	bfe24f55-d0e5-254a-e053-2995a90a2fd3	2024-10-16	Warnings	Exact identifier unii: 15FIX9V2JP
Equate Sunscreen SPF 50 KIDS Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	WAL-MART STORES INC	81cb6b2e-1ca3-4a83-a8df-9bfee61e79af	2024-10-16	Warnings	Exact identifier unii: 15FIX9V2JP
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	7219022c-a56a-4501-9437-601f6cb34e6b	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: MNX7R8C5VO unii: 46627O600J
MINERAL BASED SPF 50 SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	THE KROGER COMPANY	a4e6936d-a76c-e8fd-e053-2995a90a965f	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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