TROMETHAMINE
- Product NDC
- 0264-8031
- 11-digit product format
- 002648031
- Labeler code
- 0264
- Product ID
- 0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- ANDA211558
- Marketing category
- ANDA
- Marketing start
- 2025-08-27
- Substance
- TROMETHAMINE
- Active strength
- 3.6 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TROMETHAMINE
- Listing expiration
- 2026-12-31
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 |
|---|
| 0264-8031-10 | TROMETHAMINE | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | | 7 |
| 0264-8031-10 | TROMETHAMINE | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0264-8031-10 | 00264803110 | 24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAG | 24 bag | 2025-08-27 | No | No | Historical |