ARGATROBAN
- Product NDC
- 16729-430
- 11-digit product format
- 167290430
- Labeler code
- 16729
- Product ID
- 16729-430_525900ef-aa6b-7f43-e063-6294a90a27de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Argatroban
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- NDA212035
- Marketing category
- NDA
- Marketing start
- 2021-10-07
- 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
- 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 | 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 |
|---|
| 16729-430-11 | ARGATROBAN | 1 in 1 CARTON | INJECTION | 1 | | 8 |
| 16729-430-11 | ARGATROBAN | 50 mL in 1 VIAL, SINGLE-USE | INJECTION | 50 | | 8 |
| 16729-430-43 | ARGATROBAN | 50 mL in 1 VIAL, SINGLE-USE | INJECTION | 50 | | 8 |
| 16729-430-43 | ARGATROBAN | 10 in 1 CARTON | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-430 | ARGATROBAN INJECTION [ACCORD HEALTHCARE INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241006_46cdf9e6-839c-49c8-9ee1-c30cfdd9368d.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 |
|---|
| 16729-430-11 | 16729043011 | 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE | 2021-10-07 | 0000-00-00 | No | No | Current |
| 16729-430-43 | 16729043043 | 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE | 2021-10-07 | 0000-00-00 | No | No | Current |