Premasol - sulfite-free (Amino Acid)
- Product NDC
- 0338-1130
- 11-digit product format
- 003381130
- Labeler code
- 0338
- Product ID
- 0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727c
- 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 Company
- Application
- ANDA075880
- Marketing category
- ANDA
- Marketing start
- 2003-06-19
- Substance
- ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active strength
- .54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 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; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Amino Acid [EPC], Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Premasol - sulfite-free (Amino Acid)
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALANINE | .54 g/100mL |
| ARGININE | 1.2 g/100mL |
| ASPARTIC ACID | .32 g/100mL |
| CYSTEINE HYDROCHLORIDE | .016 g/100mL |
| GLUTAMIC ACID | .5 g/100mL |
| GLYCINE | .36 g/100mL |
| HISTIDINE | .48 g/100mL |
| ISOLEUCINE | .82 g/100mL |
| LEUCINE | 1.4 g/100mL |
| LYSINE ACETATE | .82 g/100mL |
| METHIONINE | .34 g/100mL |
| PHENYLALANINE | .48 g/100mL |
| PROLINE | .68 g/100mL |
| SERINE | .38 g/100mL |
| TAURINE | 25 mg/100mL |
| THREONINE | .42 g/100mL |
| TRYPTOPHAN | .2 g/100mL |
| TYROSINE | .24 g/100mL |
| VALINE | .78 g/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | OF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, ZT934N0X4W, 3KX376GY7L, TE7660XO1C, 4QD397987E, 04Y7590D77, GMW67QNF9C, TTL6G7LIWZ, AE28F7PNPL, 47E5O17Y3R, 9DLQ4CIU6V, 452VLY9402, 1EQV5MLY3D, 2ZD004190S, 8DUH1N11BX, 42HK56048U, HG18B9YRS7 |
| Rxcui | 801395, 801398, 801403, 801405 |
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 |
|---|---|---|---|---|---|---|
| 0338-1130-03 | Premasol - sulfite-free (Amino Acid) | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 12 | |
| 0338-1130-04 | Premasol - sulfite-free (Amino Acid) | 1000 mL in 1 BAG | INJECTION, SOLUTION | 1000 | 12 | |
| 0338-1130-06 | Premasol - sulfite-free (Amino Acid) | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-1130-03 | ML - Milliliter | 0338-1130 | d19f9eba-b809-475b-92d8-dc351eb8d78f | 1 | 2012-07-24 |
| 0338-1130-04 | ML - Milliliter | 0338-1130 | 9cba055e-6573-425b-aac6-6cd285e76078 | 1 | 2012-07-24 |
| 0338-1130-06 | ML - Milliliter | 0338-1130 | 9f8ad992-7fbc-44e8-a280-9063b6d52e49 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-1130 | 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 | Current NDC, Legacy NDC, 3 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 |
|---|---|---|---|---|---|---|---|---|
| 0338-1130-03 | 00338113003 | 500 mL in 1 BAG (0338-1130-03) | 500 ml | 2003-06-19 | 0000-00-00 | No | No | Current |
| 0338-1130-04 | 00338113004 | 1000 mL in 1 BAG (0338-1130-04) | 1000 ml | 2003-06-19 | 0000-00-00 | No | No | Current |
| 0338-1130-06 | 00338113006 | 2000 mL in 1 BAG (0338-1130-06) | 2000 ml | 2003-06-19 | 0000-00-00 | No | No | Current |