thrombin human
- Product NDC
- 63713-461
- 11-digit product format
- 637130461
- Labeler code
- 63713
- Product ID
- 63713-461_374e14e3-6a79-c213-e063-6394a90af910
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- thrombin human
- Dosage form
- POWDER, FOR SOLUTION
- Route
- TOPICAL
- Labeler
- Ethicon, Inc
- Application
- BLA125247
- Marketing category
- BLA
- Marketing start
- 2009-09-19
- Substance
- HUMAN THROMBIN
- Active strength
- 2000 [iU]/2mL
- Pharmacologic classes
- Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- thrombin human
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN THROMBIN | 2000 [iU]/2mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63713-461-02 | thrombin human | 2 mL in 1 VIAL, GLASS | POWDER, FOR SOLUTION | 2 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| thrombin human | ACTIVE INGREDIENT | 6K15ABL77G | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
| thrombin | ACTIVE MOIETY | 25ADE2236L | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
| albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
| calcium chloride | INACTIVE INGREDIENT | M4I0D6VV5M | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63713-461 | THROMBIN HUMAN POWDER, FOR SOLUTION [ETHICON, INC] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240529_02edcd44-1c26-45f1-a75c-f1f639d1956e.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 |
|---|
| 63713-461-02 | 63713046102 | 2 mL in 1 VIAL, GLASS (63713-461-02) | 2 ml | 2009-09-19 | 0000-00-00 | No | No | Current |