Premasol - sulfite-free (Amino Acid)
- Product NDC
- 0338-1131
- 11-digit product format
- 003381131
- Labeler code
- 0338
- Product ID
- 0338-1131_49eb2f11-79ad-47ec-8c8f-7ebbf0490285
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA075880
- Marketing category
- ANDA
- Marketing start
- 2003-06-19
- Marketing end
- 0000-00-00
- Substance
- LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE
- Active strength
- 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL
- Pharmacologic classes
- Amino Acid [EPC],Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-1131-03 | Premasol - sulfite-free (Amino Acid) | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-1131-03 | ML - Milliliter | 0338-1131 | d27739ee-97d6-4bab-9b90-6212fa07dd92 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-1131 | PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 10 | Legacy NDC, 1 package rows | 20240315_9afdcc3e-0d06-47f4-86ca-40da48b2b02b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801405 | PremaSol 10 % Injectable Solution | PSN | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801398 | PremaSol 6 % Injectable Solution | PSN | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801398 | alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution [PremaSol] | SBD | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801405 | alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution [PremaSol] | SBD | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801395 | alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution | SCD | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801403 | alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution | SCD | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801405 | PremaSol 10 % Amino Acids Injectable Solution | SY | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
| 801398 | PremaSol 6 % Amino Acids Injectable Solution | SY | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-1131-03 | 00338113103 | 500 mL in 1 BAG (0338-1131-03) | 500 ml | 2003-06-19 | 0000-00-00 | No | No | Current |