Argatroban
- Product NDC
- 67457-212
- 11-digit product format
- 674570212
- Labeler code
- 67457
- Product ID
- 67457-212_08b6fbe4-ad4f-45eb-aad5-0b6bac026652
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- argatroban
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA202626
- Marketing category
- ANDA
- Marketing start
- 2017-11-14
- Substance
- ARGATROBAN
- Active strength
- 250 mg/2.5mL
- Pharmacologic classes
- Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Argatroban
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARGATROBAN | 250 mg/2.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IY90U61Z3S |
| Rxcui | 308351 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-212-02 | Argatroban | 2.5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2.5 | | 6 |
| 67457-212-02 | Argatroban | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-212 | ARGATROBAN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210729_b0dedf95-8395-46bf-b94a-dcf2dd085942.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-212-02 | 67457021202 | 1 VIAL, GLASS in 1 CARTON (67457-212-02) / 2.5 mL in 1 VIAL, GLASS | 2017-11-14 | 0000-00-00 | No | No | Current |