Perikabiven
- Product NDC
- 63323-714
- 11-digit product format
- 633230714
- Labeler code
- 63323
- Product ID
- 63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary 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
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA200656
- Marketing category
- NDA
- Marketing start
- 2014-08-25
- Substance
- 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 ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active 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 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
- Pharmacologic classes
- 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 Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Perikabiven
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALANINE | 333 mg/100mL |
| ARGININE | 235 mg/100mL |
| ASPARTIC ACID | 71 mg/100mL |
| CALCIUM CHLORIDE | 20 mg/100mL |
| DEXTROSE MONOHYDRATE | 7.5 g/100mL |
| GLUTAMIC ACID | 116 mg/100mL |
| GLYCINE | 164 mg/100mL |
| HISTIDINE | 141 mg/100mL |
| ISOLEUCINE | 116 mg/100mL |
| LEUCINE | 164 mg/100mL |
| LYSINE HYDROCHLORIDE | 187 mg/100mL |
| MAGNESIUM SULFATE HEPTAHYDRATE | 68 mg/100mL |
| METHIONINE | 116 mg/100mL |
| PHENYLALANINE | 164 mg/100mL |
| POTASSIUM CHLORIDE | 124 mg/100mL |
| PROLINE | 141 mg/100mL |
| SERINE | 94 mg/100mL |
| SODIUM ACETATE | 170 mg/100mL |
| SODIUM GLYCEROPHOSPHATE ANHYDROUS | 105 mg/100mL |
| SOYBEAN OIL | 3.5 g/100mL |
| THREONINE | 116 mg/100mL |
| TRYPTOPHAN | 40 mg/100mL |
| TYROSINE | 4.8 mg/100mL |
| VALINE | 152 mg/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | OF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, M4I0D6VV5M, LX22YL083G, 3KX376GY7L, TE7660XO1C, 4QD397987E, 04Y7590D77, GMW67QNF9C, JNJ23Q2COM, SK47B8698T, AE28F7PNPL, 47E5O17Y3R, 660YQ98I10, 9DLQ4CIU6V, 452VLY9402, 4550K0SC9B, YP1H63LJ2K, 241ATL177A |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-714-14 | Perikabiven | 1440 mL in 1 BAG | INJECTION, EMULSION | 1440 | 9 | |
| 63323-714-19 | Perikabiven | 1920 mL in 1 BAG | INJECTION, EMULSION | 1920 | 9 | |
| 63323-714-24 | Perikabiven | 2400 mL in 1 BAG | INJECTION, EMULSION | 2400 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-714-14 | ML - Milliliter | 63323-714 | efa5a6b9-9583-4c57-975d-01176754c596 | 1 | 2014-10-03 |
| 63323-714-19 | ML - Milliliter | 63323-714 | 602f0e18-829f-4b2c-b323-cbcd7ab4079a | 1 | 2014-10-03 |
| 63323-714-24 | ML - Milliliter | 63323-714 | 72822b73-e0f5-4dff-b0b6-e405f77ca92a | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-714 | PERIKABIVEN (DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE) INJECTION, EMULSION [FRESENIUS KABI USA, LLC ] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230829_c2eb5522-8572-45f4-869d-42f9fd251bb6.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-714-14 | 63323071414 | 1440 mL in 1 BAG (63323-714-14) | 1440 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-714-19 | 63323071419 | 1920 mL in 1 BAG (63323-714-19) | 1920 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-714-24 | 63323071424 | 2400 mL in 1 BAG (63323-714-24) | 2400 ml | 2014-08-25 | 0000-00-00 | No | No | Current |