Travasol
- Product NDC
- 0338-0644
- 11-digit product format
- 003380644
- Labeler code
- 0338
- Product ID
- 0338-0644_e0279078-016d-48fd-8de1-c894422b33ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA018931
- Marketing category
- NDA
- Marketing start
- 1984-08-23
- Substance
- LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE
- Active strength
- 730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/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 |
|---|---|---|---|---|---|---|---|
| N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | AMINO ACIDS | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | ||
| N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | ||
| N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | AMINO ACIDS | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018931-002 | TRAVASOL 8.5% IN PLASTIC CONTAINER | 8.5% (8.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018931-003 | TRAVASOL 10% IN PLASTIC CONTAINER | 10% (10MG/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018931-001 | TRAVASOL 5.5% IN PLASTIC CONTAINER | 5.5% (5.5GM/100ML) | INJECTABLE / INJECTION | 1984-08-23 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Travasol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEUCINE | 730 mg/100mL |
| PHENYLALANINE | 560 mg/100mL |
| LYSINE HYDROCHLORIDE | 580 mg/100mL |
| METHIONINE | 400 mg/100mL |
| ISOLEUCINE | 600 mg/100mL |
| VALINE | 580 mg/100mL |
| HISTIDINE | 480 mg/100mL |
| THREONINE | 420 mg/100mL |
| TRYPTOPHAN | 180 mg/100mL |
| ALANINE | 2.07 g/100mL |
| GLYCINE | 1.03 g/100mL |
| ARGININE | 1.15 g/100mL |
| PROLINE | 680 mg/100mL |
| TYROSINE | 40 mg/100mL |
| SERINE | 500 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| GMW67QNF9C | Internal UNII lookup |
| 47E5O17Y3R | Internal UNII lookup |
| JNJ23Q2COM | Internal UNII lookup |
| AE28F7PNPL | Internal UNII lookup |
| 04Y7590D77 | Internal UNII lookup |
| HG18B9YRS7 | Internal UNII lookup |
| 4QD397987E | Internal UNII lookup |
| 2ZD004190S | Internal UNII lookup |
| 8DUH1N11BX | Internal UNII lookup |
| OF5P57N2ZX | Internal UNII lookup |
| TE7660XO1C | Internal UNII lookup |
| 94ZLA3W45F | Internal UNII lookup |
| 9DLQ4CIU6V | Internal UNII lookup |
| 42HK56048U | Internal UNII lookup |
| 452VLY9402 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 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 |
|---|---|---|---|---|---|---|
| 0338-0644-03 | Travasol | 500 mL in 1 BAG | INJECTION | 500 | 16 | |
| 0338-0644-04 | Travasol | 1000 mL in 1 BAG | INJECTION | 1000 | 16 | |
| 0338-0644-06 | Travasol | 2000 mL in 1 BAG | INJECTION | 2000 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0644-03 | ML - Milliliter | 0338-0644 | dd8a4fd4-2622-4551-a968-31de7cad2d24 | 1 | 2012-07-24 |
| 0338-0644-04 | ML - Milliliter | 0338-0644 | 64841eba-8f29-421a-a615-01b4e94e1137 | 1 | 2012-07-24 |
| 0338-0644-06 | ML - Milliliter | 0338-0644 | 49a8fb2d-3a35-4762-a3d4-ed1da77c7f6c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0644 | TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION] | 16 | Current NDC, Legacy NDC, 3 package rows | 20250209_8543b5be-0f43-4891-9e56-d7c39fe839b5.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Travasol | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE | Baxter Healthcare Corporation | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 2020-10-07 | Warnings, Adverse reactions | 018931 NDA018931 0338-0644 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801648 | Travasol 10 % Injectable Solution | PSN | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 16 |
| 801648 | alanine 20.7 MG/ML / arginine 11.5 MG/ML / glycine 10.3 MG/ML / histidine 4.8 MG/ML / isoleucine 6 MG/ML / leucine 7.3 MG/ML / lysine 5.8 MG/ML / methionine 4 MG/ML / phenylalanine 5.6 MG/ML / proline 6.8 MG/ML / serine 5 MG/ML / threonine 4.2 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.4 MG/ML / valine 5.8 MG/ML Injectable Solution [Travasol 10] | SBD | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 16 |
| 801644 | alanine 20.7 MG/ML / arginine 11.5 MG/ML / glycine 10.3 MG/ML / histidine 4.8 MG/ML / isoleucine 6 MG/ML / leucine 7.3 MG/ML / lysine 5.8 MG/ML / methionine 4 MG/ML / phenylalanine 5.6 MG/ML / proline 6.8 MG/ML / serine 5 MG/ML / threonine 4.2 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.4 MG/ML / valine 5.8 MG/ML Injectable Solution | SCD | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 16 |
| 801648 | Travasol 10 % Injectable Solution | SY | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0644-03 | 00338064403 | 500 mL in 1 BAG (0338-0644-03) | 500 ml | 1984-08-23 | 0000-00-00 | No | No | Current |
| 0338-0644-04 | 00338064404 | 1000 mL in 1 BAG (0338-0644-04) | 1000 ml | 1984-08-23 | 0000-00-00 | No | No | Current |
| 0338-0644-06 | 00338064406 | 2000 mL in 1 BAG (0338-0644-06) | 2000 ml | 1984-08-23 | 0000-00-00 | No | No | Current |