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 116 of 129 · 2,566 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a8fffe38-5f90-4078-b553-30036659a2ee	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	bfa2b2be-958c-439f-b363-2623df2b8501	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15f73322-0b27-4412-b368-84bc768f55e8	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b70b8ffc-091a-4969-86a7-6c3e1b9b9d74	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15fe0429-720c-4975-953d-285aa7ee12ce	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	1a733548-75a4-41ec-8d8d-3e6e9aad52e0	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	f43c867a-161f-47b7-b3d8-7f7e6c672804	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	0d75be99-7607-4964-bb6e-3c731644ab4e	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	82d210bc-b7ca-4d74-be58-85f175a75058	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	NEWCO LLC	fa3c73a3-0dfb-4673-822a-45d946dee260	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	867a88df-9a18-447f-8301-2ec91566302e	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	bf766aab-a52d-41e8-a06a-f2e536d2219b	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
PROJECT REEF SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	6bcd470c-6994-4d28-8370-4cc9d68e1e78	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30	TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE	O'Skin Studio NY	d84cca38-b673-484e-aa25-df58d904d4d3	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Aruba Aloe Balm NV	80461b6d-b1b7-4220-894d-8bd425909474	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Image Prevention Refiner Primer SPF50	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0e490f11-666c-420c-8c12-b45cd238ce47	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 01 Light	TITANIUM DIOXIDE	Farmasi US LLC	97c1da03-b79c-46a3-a9f0-7aeb94ed66da	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan	TITANIUM DIOXIDE	Farmasi US LLC	deee5784-c68b-4cd7-acbf-f64391a01bfc	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium	TITANIUM DIOXIDE	Farmasi US LLC	cef1a926-b7d4-47d6-957d-e3092e60970c	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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