Plenamine
- Product NDC
- 0264-4500
- 11-digit product format
- 002644500
- Labeler code
- 0264
- Product ID
- 0264-4500_905f7c55-bf0d-4150-90ef-e8f1a5455bc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- ANDA091112
- Marketing category
- ANDA
- Marketing start
- 2018-09-28
- Substance
- ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active strength
- 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Amino Acid [EPC], Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0264-4500-00 | Plenamine | 8 in 1 CASE | SOLUTION | 8 | | 9 |
| 0264-4500-00 | Plenamine | 1000 mL in 1 CONTAINER | SOLUTION | 1000 | | 9 |
| 0264-4500-05 | Plenamine | 4 in 1 CASE | SOLUTION | 4 | | 9 |
| 0264-4500-05 | Plenamine | 2000 mL in 1 CONTAINER | SOLUTION | 2000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0264-4500 | PLENAMINE (LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE) SOLUTION [B. BRAUN MEDICAL INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20230427_a3244d1a-45b0-4e4c-bd96-f0632d761a1f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1601982 | Plenamine 15 % Injectable Solution | PSN | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 9 |
| 1601982 | alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution [Plenamine] | SBD | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 9 |
| 800584 | alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution | SCD | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 9 |
| 1601982 | Plenamine 15 % Amino Acids Injection | SY | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 9 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0264-4500-00 | 00264450000 | 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER | 8 container | 2018-09-28 | 0000-00-00 | No | No | Current |
| 0264-4500-05 | 00264450005 | 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER | 4 container | 2019-10-29 | 0000-00-00 | No | No | Current |