recothrom

Generic: thrombin topical recombinant

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name recothrom
Generic Name thrombin topical recombinant
Labeler baxter healthcare corporation
Dosage Form KIT
Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0322
Product ID 0338-0322_dfa7d1e1-447c-44fb-bcbe-7e01a0c08297
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125248
Listing Expiration 2027-12-31
Marketing Start 2008-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380322
Hyphenated Format 0338-0322

Supplemental Identifiers

RxCUI
1367418 1367420

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name recothrom (source: ndc)
Generic Name thrombin topical recombinant (source: ndc)
Application Number BLA125248 (source: ndc)

Resolved Composition

Strengths
  • 0.9 %
  • 1000 unit/ml
source: label
Packaging
  • 1 KIT in 1 KIT (0338-0322-01) * 5 mL in 1 VIAL (0338-0324-01) * 5 mL in 1 SYRINGE
source: ndc

Packages (1)

0338-0322-01 1 KIT in 1 KIT (0338-0322-01) * 5 mL in 1 VIAL (0338-0324-01) * 5 mL in 1 SYRINGE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

RECOTHROM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "dfa7d1e1-447c-44fb-bcbe-7e01a0c08297", "openfda": {"rxcui": ["1367418", "1367420"], "spl_set_id": ["54885644-e51e-4263-aadb-366abaeb56a3"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (0338-0322-01)  *  5 mL in 1 VIAL (0338-0324-01)  *  5 mL in 1 SYRINGE", "package_ndc": "0338-0322-01", "marketing_start_date": "20080129"}], "brand_name": "RECOTHROM", "product_id": "0338-0322_dfa7d1e1-447c-44fb-bcbe-7e01a0c08297", "dosage_form": "KIT", "product_ndc": "0338-0322", "generic_name": "thrombin topical recombinant", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RECOTHROM", "application_number": "BLA125248", "marketing_category": "BLA", "marketing_start_date": "20080129", "listing_expiration_date": "20271231"}