ARGATROBAN
- Product NDC
- 65145-126
- 11-digit product format
- 651450126
- Labeler code
- 65145
- Product ID
- 65145-126_b36d78fb-27ca-45cf-a980-335364fe53c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Argatroban
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA214235
- Marketing category
- ANDA
- Marketing start
- 2026-04-17
- 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
- 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 | 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 |
|---|
| 65145-126-01 | ARGATROBAN | 50 mL in 1 VIAL | INJECTION | 50 | | 5 |
| 65145-126-01 | ARGATROBAN | 1 in 1 CARTON | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-126 | ARGATROBAN INJECTION [CAPLIN STERILES LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241006_b5143563-ff45-433a-a9e2-f8b8340db1f5.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 |
|---|
| 65145-126-01 | 65145012601 | 1 VIAL in 1 CARTON (65145-126-01) / 50 mL in 1 VIAL | 1 vial | 2026-04-17 | 0000-00-00 | No | No | Current |