ProSol
- Product NDC
- 0338-0499
- 11-digit product format
- 003380499
- Labeler code
- 0338
- Product ID
- 0338-0499_ee240b46-c2a9-42e0-8750-a5a554becea3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA020849
- Marketing category
- NDA
- Marketing start
- 1998-08-26
- Substance
- ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active strength
- 2.76; 1.96; 600; 1.02; 2.06; 1.18; 1.08; 1.08; 1.35; 760; 1; 1.34; 1.02; 980; 320; 50; 1.44 g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL
- Pharmacologic classes
- Amino Acid [EPC], Amino Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020849-001 | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | AMINO ACIDS | 20% (20GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1998-08-26 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N020849-001 | PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | 20% (20GM/100ML) | INJECTABLE / INJECTION | RLD, RS | 1998-08-26 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ProSol | VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Baxter Healthcare Corporation | cc2ace81-5881-43f1-ba94-41b674adc2fc | 2020-10-07 | Warnings, Adverse reactions | 020849 NDA020849 0338-0499 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ProSol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VALINE | 2.76 g/100mL |
| LYSINE ACETATE | 1.96 g/100mL |
| HISTIDINE | 600 mg/100mL |
| ISOLEUCINE | 1.02 g/100mL |
| LEUCINE | 2.06 g/100mL |
| PHENYLALANINE | 1.18 g/100mL |
| THREONINE | 1.08 g/100mL |
| METHIONINE | 1.08 g/100mL |
| TRYPTOPHAN | 1.35 g/100mL |
| ALANINE | 760 mg/100mL |
| GLYCINE | 1 g/100mL |
| ARGININE | 1.34 g/100mL |
| PROLINE | 1.02 g/100mL |
| GLUTAMIC ACID | 980 mg/100mL |
| SERINE | 320 mg/100mL |
| ASPARTIC ACID | 50 mg/100mL |
| TYROSINE | 1.44 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| HG18B9YRS7 | Internal UNII lookup |
| TTL6G7LIWZ | Internal UNII lookup |
| 4QD397987E | Internal UNII lookup |
| 04Y7590D77 | Internal UNII lookup |
| GMW67QNF9C | Internal UNII lookup |
| 47E5O17Y3R | Internal UNII lookup |
| 2ZD004190S | Internal UNII lookup |
| AE28F7PNPL | Internal UNII lookup |
| 8DUH1N11BX | Internal UNII lookup |
| OF5P57N2ZX | Internal UNII lookup |
| TE7660XO1C | Internal UNII lookup |
| 94ZLA3W45F | Internal UNII lookup |
| 9DLQ4CIU6V | Internal UNII lookup |
| 3KX376GY7L | Internal UNII lookup |
| 452VLY9402 | Internal UNII lookup |
| 30KYC7MIAI | Internal UNII lookup |
| 42HK56048U | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cc2ace81-5881-43f1-ba94-41b674adc2fc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 0338-0499-06 | ProSol | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0499-06 | ML - Milliliter | 0338-0499 | 340ccc36-c96c-40f4-ae26-6b203cc63711 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0499 | PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 14 | Current NDC, Legacy NDC, 1 package rows | 20250112_cc2ace81-5881-43f1-ba94-41b674adc2fc.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801136 | ProSol 20 % Injectable Solution | PSN | cc2ace81-5881-43f1-ba94-41b674adc2fc | 14 |
| 801136 | alanine 27.6 MG/ML / arginine 19.6 MG/ML / aspartate 6 MG/ML / glutamate 10.2 MG/ML / glycine 20.6 MG/ML / histidine 11.8 MG/ML / isoleucine 10.8 MG/ML / leucine 10.8 MG/ML / lysine 13.5 MG/ML / methionine 7.6 MG/ML / phenylalanine 10 MG/ML / proline 13.4 MG/ML / serine 10.2 MG/ML / threonine 9.8 MG/ML / tryptophan 3.2 MG/ML / tyrosine 0.5 MG/ML / valine 14.4 MG/ML Injectable Solution [Prosol] | SBD | cc2ace81-5881-43f1-ba94-41b674adc2fc | 14 |
| 801133 | alanine 27.6 MG/ML / arginine 19.6 MG/ML / aspartate 6 MG/ML / glutamate 10.2 MG/ML / glycine 20.6 MG/ML / histidine 11.8 MG/ML / isoleucine 10.8 MG/ML / leucine 10.8 MG/ML / lysine 13.5 MG/ML / methionine 7.6 MG/ML / phenylalanine 10 MG/ML / proline 13.4 MG/ML / serine 10.2 MG/ML / threonine 9.8 MG/ML / tryptophan 3.2 MG/ML / tyrosine 0.5 MG/ML / valine 14.4 MG/ML Injectable Solution | SCD | cc2ace81-5881-43f1-ba94-41b674adc2fc | 14 |
| 801136 | ProSol 20 % Amino Acid Injectable Solution | SY | cc2ace81-5881-43f1-ba94-41b674adc2fc | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0499-06 | 00338049906 | 2000 mL in 1 BAG (0338-0499-06) | 2000 ml | 1998-08-26 | 0000-00-00 | No | No | Current |