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NDC 63323-0714-24 Perikabiven 333; 235; 71; 20; 7.5; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Details
Perikabiven 333; 235; 71; 20; 7.5; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Perikabiven is a INTRAVENOUS INJECTION, EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM .
Product Information
| NDC | 63323-0714 |
|---|---|
| Product ID | 63323-714_19ddcce5-fefc-428d-a57a-7df023363e25 |
| Associated GPIs | 80451010001626 |
| GCN Sequence Number | 085282 |
| GCN Sequence Number Description | AA 2.36%/D7.5W/fat/e-lytes no9 EMULSION 2.36%-7.5% INTRAVEN |
| HIC3 | C9C |
| HIC3 Description | PARENTERAL AMINO ACID SOLUTIONS AND COMBINATIONS |
| GCN | 54726 |
| HICL Sequence Number | 049206 |
| HICL Sequence Number Description | AMINO ACID 2.36 % NO.1/D7.5W/FAT EMULSIONS/ELECTROLYTES NO.9 |
| Brand/Generic | Brand |
| Proprietary Name | Perikabiven |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, EMULSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 333; 235; 71; 20; 7.5; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152 |
| Active Ingredient Units | mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL |
| Substance Name | ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Mot |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA200656 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0714-24 (63323071424)
| NDC Package Code | 63323-714-24 |
|---|---|
| Billing NDC | 63323071424 |
| Package | 2400 mL in 1 BAG (63323-714-24) |
| Marketing Start Date | 2014-08-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |