Argatroban
- Product NDC
- 83301-0062
- 11-digit product format
- 833010062
- Labeler code
- 83301
- Product ID
- 83301-0062_8b45a05d-47a6-4a64-b232-108bd7185eba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Argatroban
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mullan Pharmaceutical Inc.
- Application
- ANDA217848
- Marketing category
- ANDA
- Marketing start
- 2026-01-01
- Substance
- ARGATROBAN
- Active strength
- 50 mg/50mL
- 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 | 50 mg/50mL |
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 |
|---|
| 83301-0062-1 | Argatroban | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 1 |
| 83301-0062-1 | Argatroban | 1 in 1 CARTON | INJECTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83301-0062-1 | 83301006201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1) / 50 mL in 1 VIAL, SINGLE-DOSE | 2026-01-01 | No | No | Current |