Tromethamine
- Product NDC
- 71357-001
- 11-digit product format
- 713570001
- Labeler code
- 71357
- Product ID
- 71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- MILLA PHARMACEUTICALS INC.
- Application
- ANDA213116
- Marketing category
- ANDA
- Marketing start
- 2024-12-31
- Substance
- TROMETHAMINE
- Active strength
- 3.6 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TROMETHAMINE | 3.6 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 023C2WHX2V |
| Rxcui | 198412 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71357-001-01 | Tromethamine | 6 in 1 CASE | INJECTION, SOLUTION | 6 | | 3 |
| 71357-001-06 | Tromethamine | 500 mL in 1 BOTTLE, GLASS | INJECTION, SOLUTION | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71357-001 | TROMETHAMINE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20250101_082b1104-502b-47af-95bf-0dbf2422990e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71357-001-01 | 71357000101 | 6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06) | | 2024-12-31 | No | No | Current |
| 71357-001-06 | 71357000106 | 500 mL in 1 BOTTLE, GLASS | 500 ml | | | | Historical |