16571-692 NDC - CARBIDOPA, LEVODOPA AND ENTACAPONE

Drug Information

Product NDC: 16571-692
Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Non Proprietary Name: CARBIDOPA, LEVODOPA AND ENTACAPONE
Active Ingredient(s): 31.25 mg/1 CARBIDOPA; 200 mg/1 ENTACAPONE; 125 mg/1 LEVODOPA
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Pharmacy Class(es): Amino Acids; Aromatic [CS]; Aromatic Amino Acid [EPC]; Catechol O-Methyltransferase Inhibitors [MoA]; Catechol-O-Methyltransferase Inhibitor [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Rising Pharma Holdings, Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA213212
Marketing Category:	ANDA
Start Marketing Date:	8/5/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	16571-692-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-692-01)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	16571-692	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME	CARBIDOPA, LEVODOPA AND ENTACAPONE	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	CARBIDOPA, LEVODOPA AND ENTACAPONE	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, FILM COATED	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/5/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	Name of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBER	ANDA213212	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
LABELER NAME	Rising Pharma Holdings, Inc.	This is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAME	CARBIDOPA; ENTACAPONE; LEVODOPA	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
ACTIVE NUMERATOR STRENGTH	31.25; 200; 125
ACTIVE INGRED UNIT	mg/1; mg/1; mg/1
PHARM CLASSES	Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]

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This page was last updated on: 2/5/2026

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