RECOTHROM
- Product NDC
- 0338-0326
- 11-digit product format
- 003380326
- Labeler code
- 0338
- Product ID
- 0338-0326_dfa7d1e1-447c-44fb-bcbe-7e01a0c08297
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- thrombin topical recombinant
- Dosage form
- KIT
- Labeler
- Baxter Healthcare Corporation
- Application
- BLA125248
- Marketing category
- BLA
- Marketing start
- 2008-06-09
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RECOTHROM
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 1367418, 1367420 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-0326-01 | RECOTHROM | 1 in 1 KIT | KIT | 1 | 15 | |
| 0338-0328-01 | RECOTHROM | 20 mL in 1 VIAL | POWDER, FOR SOLUTION | 20 mL | 1000 [iU] in 1mL | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0326-01 | EA - Each | 0338-0326 | ba97e843-25f4-4e7a-9779-85b7e5fee6d8 | 1 | 2019-12-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1367420 | Recothrom 1000 UNT in 1 ML Topical Solution | PSN | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367418 | thrombin alfa 1000 UNT in 1 ML Topical Solution | PSN | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367420 | thrombin alfa 1000 UNT/ML Topical Solution [Recothrom] | SBD | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367418 | thrombin alfa 1000 UNT/ML Topical Solution | SCD | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367418 | alfa-thrombin 1000 UNT/ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367420 | Recothrom 1000 UNT per 1 ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367420 | Recothrom 1000 UNT/ML (as alfa-thrombin) Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367420 | Recothrom 20,000 UNT per 20 ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367420 | Recothrom 5,000 UNT per 5 ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367418 | thrombin alfa 1000 UNT per 1 ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
| 1367418 | thrombin alfa 20,000 UNT per 20 ML Topical Solution | SY | 54885644-e51e-4263-aadb-366abaeb56a3 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0338-0326-01 | 00338032601 | 1 KIT in 1 KIT (0338-0326-01) * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 SYRINGE | 1 kit | 2008-06-09 | 0000-00-00 | No | No | Current |
| 0338-0328-01 | 00338032801 | 20 mL in 1 VIAL | 20 ml | Historical |