NDC 0264-1915

ProcalAmine

Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite

ProcalAmine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Glycerin; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Alanine; Glycine; Arginine; Histidine; Proline; Serine; Cysteine Hydrochloride; Sodium Acetate; Magnesium Acetate; Calcium Acetate; Sodium Chloride; Potassium Chloride; Phosphoric Acid.

• Product ID: 0264-1915_25a5bf4f-c79d-4ff2-a538-3c0a218ea850
• NDC: 0264-1915
• Product Type: Human Prescription Drug
• Proprietary Name: ProcalAmine
• Generic Name: Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1982-05-06
• Marketing Category: NDA / NDA
• Application Number: NDA018582
• Labeler Name: B. Braun Medical Inc.
• Substance Name: GLYCERIN; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; GLYCINE; ARGININE; HISTIDINE; PROLINE; SERINE; CYSTEINE HYDROCHLORIDE; SODIUM ACETATE; MAGNESIUM ACETATE; CALCIUM ACETATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; PHOSPHORIC ACID
• Active Ingredient Strength: 3 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; g/100mL; g/100mL
• Pharm Classes: Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Glycerol [CS],Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0264-1915-07

6 CARTON in 1 CASE (0264-1915-07) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER

• Marketing Start Date: 1982-05-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-1915-07 [00264191507]

ProcalAmine INJECTION

• Marketing Category: NDA
• Application Number: NDA018582
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1982-05-06

NDC 0264-1915-00 [00264191500]

ProcalAmine INJECTION

• Marketing Category: NDA
• Application Number: NDA018582
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1982-05-06
• Marketing End Date: 2015-04-30

Drug Details

Active Ingredients

Ingredient	Strength
GLYCERIN	3 g/100mL

OpenFDA Data

• SPL SET ID: e4e9ecb0-13b2-4de9-9ef0-5c05da2734bb
• Manufacturer:
  • B. Braun Medical Inc.
• UNII:
  • AE28F7PNPL
  • 47E5O17Y3R
  • 451W47IQ8X
  • 4QD397987E
  • GMW67QNF9C
  • TTL6G7LIWZ
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 0E95JZY48K
  • OF5P57N2ZX
  • 2ZD004190S
  • PDC6A3C0OX
  • HG18B9YRS7
  • E4GA8884NN
  • 660YQ98I10
  • TE7660XO1C
  • 94ZLA3W45F
  • 4550K0SC9B
  • ZT934N0X4W
  • 452VLY9402
  • Y882YXF34X
• RxNorm Concept Unique ID - RxCUI:
  • 801413
  • 801417

Pharmacological Class

• Non-Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Allergens [CS]
• Glycerol [CS]
• Amino Acid [EPC]
• Amino Acids [CS]
• Calculi Dissolution Agent [EPC]
• Magnesium Ion Exchange Activity [MoA]
• Osmotic Laxative [EPC]
• Osmotic Activity [MoA]
• Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
• Increased Large Intestinal Motility [PE]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]