CARBOPROST TROMETHAMINE
- Product NDC
- 65219-579
- 11-digit product format
- 652190579
- Labeler code
- 65219
- Product ID
- 65219-579_9388ae75-3bda-41ee-93b5-f99313a16391
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carboprost tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA216882
- Marketing category
- ANDA
- Marketing start
- 2023-06-12
- Substance
- CARBOPROST TROMETHAMINE
- Active strength
- 250 ug/mL
- Pharmacologic classes
- Prostaglandin Analog [EPC], Prostaglandins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CARBOPROST TROMETHAMINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBOPROST TROMETHAMINE | 250 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U4526F86FJ |
| Rxcui | 238014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-579-00 | CARBOPROST TROMETHAMINE | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1 |
| 65219-579-01 | CARBOPROST TROMETHAMINE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-579 | CARBOPROST TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20230613_e5f58209-bc3d-4d9f-a372-bc14f877d16c.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 |
|---|
| 65219-579-00 | 65219057900 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 65219-579-01 | 65219057901 | 10 VIAL in 1 CARTON (65219-579-01) / 1 mL in 1 VIAL (65219-579-00) | 10 vial | 2023-06-12 | No | No | Current |