Clinimix E Injection
NDC Package 0338-1113-04
Package Information
Clinimix E (leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose) injection is cLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. This formulation utilizes a injection delivery system. Marketed by Baxter Healthcare Company, this product is identified by NDC 0338-1113 and is authorized under FDA application NDA020678.
Identification & Billing
- RxCUI: 1090635 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution
- RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic K+ phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
- RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic Pot phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
- RxCUI: 1090639 - Clinimix E 4.25/10 Injectable Solution
- RxCUI: 1090639 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix E 4.25/10]
Clinical Specifications
- LEUCINE 880 mg/100mL
- PHENYLALANINE 489 mg/100mL
- LYSINE 33 mg/100mL
- METHIONINE 5 g/100mL
- ISOLEUCINE 438 mg/100mL
- VALINE 204 mg/100mL
- HISTIDINE 255 mg/100mL
- THREONINE 311 mg/100mL
- TRYPTOPHAN 247 mg/100mL
- ALANINE 51 mg/100mL
- GLYCINE 170 mg/100mL
- ARGININE 238 mg/100mL
- PROLINE 261 mg/100mL
- SERINE 289 mg/100mL
- TYROSINE 213 mg/100mL
- SODIUM ACETATE 297 mg/100mL
- POTASSIUM PHOSPHATE, DIBASIC 77 mg/100mL
- MAGNESIUM CHLORIDE 179 mg/100mL
- SODIUM CHLORIDE 77 mg/100mL
- CALCIUM CHLORIDE 17 mg/100mL
- DEXTROSE 247 mg/100mL
- Amino Acid - [EPC] (Established Pharmacologic Class)
- Amino Acids - [CS]
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Calcium - [CS]
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Cations, Divalent - [CS]
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Phosphate Binder - [EPC] (Established Pharmacologic Class)
- Phosphate Chelating Activity - [MoA] (Mechanism of Action)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
Regulatory & Marketing
Hierarchy Structure
- 0338 - Baxter Healthcare Company
- 0338-1113 - Clinimix E
- 0338-1113-04 - 2000 mL in 1 BAG
- 0338-1113 - Clinimix E
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0338-1113-04 identifies a specific commercial package of 2000 ml in 1 bag of Clinimix E, a human prescription drug labeled by Baxter Healthcare Company. This product is billed per "ML" milliliter and contains an estimated amount of 2000 billable units per package. This injection is formulated for intravenous use and contains leucine; phenylalanine; lysine; methionine; isoleucine; valine; histidine; threonine; tryptophan; alanine; glycine; arginine; proline; serine; tyrosine; sodium acetate; potassium phosphate, dibasic; magnesium chloride; sodium chloride; calcium chloride; dextrose as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Baxter Healthcare Company on March 26, 1997. The current certification is valid through December 31, 2027.
How is this Baxter Healthcare Company product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338111304. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 2000 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
