Clinisol
- Product NDC
- 0338-0502
- 11-digit product format
- 003380502
- Labeler code
- 0338
- Product ID
- 0338-0502_7eab93b5-5590-4381-8674-113a05edeff0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA020512
- Marketing category
- ANDA
- Marketing start
- 1996-08-30
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A020512-001 | CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER | AMINO ACIDS | 15% (15GM/100ML) | INJECTABLE / INJECTION | 1996-08-30 |
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 | A020512-001 | CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER | 15% (15GM/100ML) | INJECTABLE / INJECTION | 1996-08-30 | 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 |
|---|---|---|---|---|---|---|
| Clinisol | LYSINE, LEUCINE, PHENYLALANINE, VALINE, HISTIDINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINE | Baxter Healthcare Corporation | 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 2018-06-01 | Warnings, Adverse reactions | 020512 ANDA020512 0338-0502 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clinisol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LYSINE ACETATE | 2.17 g/100mL |
| LEUCINE | 1.47 g/100mL |
| PHENYLALANINE | 434 mg/100mL |
| VALINE | 749 mg/100mL |
| HISTIDINE | 1.04 g/100mL |
| ISOLEUCINE | 894 mg/100mL |
| METHIONINE | 749 mg/100mL |
| THREONINE | 1.04 g/100mL |
| TRYPTOPHAN | 1.18 g/100mL |
| ALANINE | 749 mg/100mL |
| ARGININE | 1.04 g/100mL |
| GLYCINE | 894 mg/100mL |
| PROLINE | 592 mg/100mL |
| GLUTAMIC ACID | 749 mg/100mL |
| SERINE | 250 mg/100mL |
| ASPARTIC ACID | 39 mg/100mL |
| TYROSINE | 960 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TTL6G7LIWZ | Internal UNII lookup |
| GMW67QNF9C | Internal UNII lookup |
| 47E5O17Y3R | Internal UNII lookup |
| HG18B9YRS7 | Internal UNII lookup |
| 4QD397987E | Internal UNII lookup |
| 04Y7590D77 | Internal UNII lookup |
| AE28F7PNPL | Internal UNII lookup |
| 2ZD004190S | Internal UNII lookup |
| 8DUH1N11BX | Internal UNII lookup |
| OF5P57N2ZX | Internal UNII lookup |
| 94ZLA3W45F | Internal UNII lookup |
| TE7660XO1C | 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 |
|---|---|
| 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 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 |
|---|---|---|---|---|---|---|
| 0338-0502-03 | Clinisol | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 12 | |
| 0338-0502-06 | Clinisol | 2000 mL in 1 BAG | INJECTION, SOLUTION | 2000 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0502-03 | ML - Milliliter | 0338-0502 | 75341093-d405-474a-a161-da253f594807 | 1 | 2012-07-24 |
| 0338-0502-06 | ML - Milliliter | 0338-0502 | fcf93fdb-1dd1-4d80-9f6b-08f1d053f3c7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0502 | CLINISOL (LYSINE, LEUCINE, PHENYLALANINE, VALINE, HISTIDINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250117_65ffc962-7538-41ea-9afb-4af5fbce4c5b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 800588 | Clinisol 15 % Injectable Solution | PSN | 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 12 |
| 800588 | 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 [Clinisol 15] | SBD | 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 12 |
| 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 | 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 12 |
| 800588 | Clinisol 15 % Amino Acids Injectable Solution | SY | 65ffc962-7538-41ea-9afb-4af5fbce4c5b | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0502-03 | 00338050203 | 500 mL in 1 BAG (0338-0502-03) | 500 ml | 1996-08-30 | 0000-00-00 | No | No | Current |
| 0338-0502-06 | 00338050206 | 2000 mL in 1 BAG (0338-0502-06) | 2000 ml | 1996-08-30 | 0000-00-00 | No | No | Current |