carboprost tromethamine
- Product NDC
- 68083-584
- 11-digit product format
- 680830584
- Labeler code
- 68083
- Product ID
- 68083-584_ed3dacb6-5a1e-4499-bec2-5ec46a0399ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carboprost tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA217657
- Marketing category
- ANDA
- Marketing start
- 2023-08-07
- 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 |
|---|
| 68083-584-10 | carboprost tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 2 |
| 68083-584-10 | carboprost tromethamine | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-584 | CARBOPROST TROMETHAMINE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20230809_5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a.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 |
|---|
| 68083-584-10 | 68083058410 | 10 VIAL in 1 CARTON (68083-584-10) / 1 mL in 1 VIAL | 10 vial | 2023-08-07 | No | No | Historical |