0264-1933 NDC - TROPHAMINE (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE)

Drug Information

Product NDC: 0264-1933
Proprietary Name: TrophAmine
Non Proprietary Name: ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
Active Ingredient(s): .24 g/100mL ACETYL L-TYROSINE; .54 g/100mL ALANINE; 1.2 g/100mL ARGININE; .32 g/100mL ASPARTIC ACID; .024 g/100mL CYSTEINE HYDROCHLORIDE; .5 g/100mL GLUTAMIC ACID; .36 g/100mL GLYCINE; .48 g/100mL HISTIDINE; .82 g/100mL ISOLEUCINE; 1.4 g/100mL LEUCINE; 1.2 g/100mL LYSINE ACETATE; .34 g/100mL METHIONINE; .48 g/100mL PHENYLALANINE; .68 g/100mL PROLINE; .38 g/100mL SERINE; .025 g/100mL TAURINE; .42 g/100mL THREONINE; .2 g/100mL TRYPTOPHAN; .044 g/100mL TYROSINE; .78 g/100mL VALINE
Administration Route(s): INTRAVENOUS
Dosage Form(s): SOLUTION
Pharmacy Class(es): Amino Acid [EPC]; Amino Acids [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	B. Braun Medical Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	NDA019018
Marketing Category:	NDA
Start Marketing Date:	10/27/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	0264-1933-10	12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0264-1933	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	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	TrophAmine	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	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE	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	SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	INTRAVENOUS	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	10/27/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	NDA019018	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	B. Braun Medical Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	.24; .54; 1.2; .32; .024; .5; .36; .48; .82; 1.4; 1.2; .34; .48; .68; .38; .025; .42; .2; .044; .78
ACTIVE INGRED UNIT	g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
PHARM CLASSES	Amino Acid [EPC], Amino Acids [CS]

0264-1933 NDC - TROPHAMINE (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE)

Drug Information

Labeler Information

Package Information

NDC Record

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