Kabiven
- Product NDC
- 63323-712
- 11-digit product format
- 633230712
- Labeler code
- 63323
- Product ID
- 63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3
- 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
- 467; 330; 99; 29; 10.8; 164; 231; 199; 164; 231; 263; 96; 164; 231; 174; 199; 131; 239; 147; 3.9; 164; 55; 6.7; 213 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
- Kabiven
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALANINE | 467 mg/100mL |
| ARGININE | 330 mg/100mL |
| ASPARTIC ACID | 99 mg/100mL |
| CALCIUM CHLORIDE | 29 mg/100mL |
| DEXTROSE MONOHYDRATE | 10.8 g/100mL |
| GLUTAMIC ACID | 164 mg/100mL |
| GLYCINE | 231 mg/100mL |
| HISTIDINE | 199 mg/100mL |
| ISOLEUCINE | 164 mg/100mL |
| LEUCINE | 231 mg/100mL |
| LYSINE HYDROCHLORIDE | 263 mg/100mL |
| MAGNESIUM SULFATE HEPTAHYDRATE | 96 mg/100mL |
| METHIONINE | 164 mg/100mL |
| PHENYLALANINE | 231 mg/100mL |
| POTASSIUM CHLORIDE | 174 mg/100mL |
| PROLINE | 199 mg/100mL |
| SERINE | 131 mg/100mL |
| SODIUM ACETATE | 239 mg/100mL |
| SODIUM GLYCEROPHOSPHATE ANHYDROUS | 147 mg/100mL |
| SOYBEAN OIL | 3.9 g/100mL |
| THREONINE | 164 mg/100mL |
| TRYPTOPHAN | 55 mg/100mL |
| TYROSINE | 6.7 mg/100mL |
| VALINE | 213 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 |
|---|---|---|---|---|---|---|
| 63323-712-10 | Kabiven | 1026 mL in 1 BAG | INJECTION, EMULSION | 1026 | 9 | |
| 63323-712-15 | Kabiven | 1540 mL in 1 BAG | INJECTION, EMULSION | 1540 | 9 | |
| 63323-712-20 | Kabiven | 2053 mL in 1 BAG | INJECTION, EMULSION | 2053 | 9 | |
| 63323-712-25 | Kabiven | 2566 mL in 1 BAG | INJECTION, EMULSION | 2566 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-712-10 | ML - Milliliter | 63323-712 | 6aaa83a5-a5db-479f-88c8-adeb12d6b974 | 1 | 2014-10-03 |
| 63323-712-15 | ML - Milliliter | 63323-712 | bfad385e-8dfb-4359-bd1a-d7416eff2f9c | 1 | 2014-10-03 |
| 63323-712-20 | ML - Milliliter | 63323-712 | 06eee041-f964-4d10-90b3-c58a689c4713 | 1 | 2014-10-03 |
| 63323-712-25 | ML - Milliliter | 63323-712 | 77652dc8-50d7-4d19-b858-ebc02108c78a | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-712 | KABIVEN (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, 4 package rows | 20230822_afeb4837-a759-4484-a76e-e04611c459e7.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-712-10 | 63323071210 | 1026 mL in 1 BAG (63323-712-10) | 1026 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-712-15 | 63323071215 | 1540 mL in 1 BAG (63323-712-15) | 1540 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-712-20 | 63323071220 | 2053 mL in 1 BAG (63323-712-20) | 2053 ml | 2014-08-25 | 0000-00-00 | No | No | Current |
| 63323-712-25 | 63323071225 | 2566 mL in 1 BAG (63323-712-25) | 2566 ml | 2014-08-25 | 0000-00-00 | No | No | Current |