Argatroban
- Product NDC
- 25021-414
- 11-digit product format
- 250210414
- Labeler code
- 25021
- Product ID
- 25021-414_e24e6287-dacb-43c2-ba01-de284ac90ee1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Argatroban
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA214235
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- Substance
- ARGATROBAN
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Argatroban
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARGATROBAN | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IY90U61Z3S |
| Rxcui | 1804735 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-414-50 | Argatroban | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 25021-414-50 | Argatroban | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-414 | ARGATROBAN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221013_629aee90-3bf3-4947-a978-21cbba2e1c41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-414-50 | 25021041450 | 1 VIAL in 1 CARTON (25021-414-50) / 50 mL in 1 VIAL | 1 vial | 2021-04-15 | 0000-00-00 | No | No | Current |