Prescription drug · NDA
Kabiven NDC 63323-712
Dextrose monohydrate 10.8 g/100mL + 23 more ingredients · Injection, Emulsion · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-712-10 | 63323071210 | 1026 mL in 1 BAG (63323-712-10)Marketed from Aug 25, 2014 | |
| 63323-712-15 | 63323071215 | 1540 mL in 1 BAG (63323-712-15)Marketed from Aug 25, 2014 | |
| 63323-712-20 | 63323071220 | 2053 mL in 1 BAG (63323-712-20)Marketed from Aug 25, 2014 | |
| 63323-712-25 | 63323071225 | 2566 mL in 1 BAG (63323-712-25)Marketed from Aug 25, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Kabiven
- Generic name (nonproprietary)
- dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine
- Active ingredients
- Dextrose monohydrate — 10.8 g/100mLSoybean oil — 3.9 g/100mLSodium acetate — 239 mg/100mLPotassium chloride — 174 mg/100mLSodium glycerophosphate anhydrous — 147 mg/100mLMagnesium sulfate heptahydrate — 96 mg/100mLCalcium chloride — 29 mg/100mLLysine hydrochloride — 263 mg/100mLPhenylalanine — 231 mg/100mLLeucine — 231 mg/100mLValine — 213 mg/100mLHistidine — 199 mg/100mLThreonine — 164 mg/100mLMethionine — 164 mg/100mLIsoleucine — 164 mg/100mLTryptophan — 55 mg/100mLAlanine — 467 mg/100mLArginine — 330 mg/100mLGlycine — 231 mg/100mLProline — 199 mg/100mLGlutamic acid — 164 mg/100mLSerine — 131 mg/100mLAspartic acid — 99 mg/100mLTyrosine — 6.7 mg/100mL
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200656
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Lipids (Chemical structure)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3SPL ID f4e7d197-8c8f-4603-ae34-cd4c204d89c3SPL set ID afeb4837-a759-4484-a76e-e04611c459e7UNII LX22YL083G, 241ATL177A, 4550K0SC9B, 660YQ98I10, YP1H63LJ2K, SK47B8698T, M4I0D6VV5M, JNJ23Q2COM, 47E5O17Y3R, GMW67QNF9C, HG18B9YRS7, 4QD397987E, 2ZD004190S, AE28F7PNPL, 04Y7590D77, 8DUH1N11BX, OF5P57N2ZX, 94ZLA3W45F, TE7660XO1C, 9DLQ4CIU6V, 3KX376GY7L, 452VLY9402, 30KYC7MIAI, 42HK56048UUPC 0363323712105, 0363323712204, 0363323712150, 0363323712259
- Pharmacologic class
- Amino Acid; Blood Coagulation Factor; Calculi Dissolution Agent; Lipid Emulsion; Osmotic Laxative; Phosphate Binder; Potassium Salt
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323071210followed by a unit qualifier and the quantityPackage 63323-0712-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use: KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . KABIVEN is indicated as a source of calor…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 200656
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Perikabivendextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine | Dextrose monohydrate 7.5 g/100mL + 23 more ingredients | Injection, EmulsionIntravenous | Fresenius Kabi USA, LLC | 63323-714 |