winrevair

Generic: sotatercept-csrk

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name winrevair
Generic Name sotatercept-csrk
Labeler merck sharp & dohme llc
Dosage Form KIT
Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5090
Product ID 0006-5090_7246eda1-3e73-4bcd-8e5e-9da5f391cff5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761363
Listing Expiration 2027-12-31
Marketing Start 2024-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065090
Hyphenated Format 0006-5090

Supplemental Identifiers

RxCUI
2678937 2678943 2678945 2678947 2678948 2678949 2678950 2678951

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 winrevair (source: ndc)
Generic Name sotatercept-csrk (source: ndc)
Application Number BLA761363 (source: ndc)

Resolved Composition

Strengths
  • 45 mg
  • 60 mg
  • 1 ml
  • 1.3 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (0006-5090-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89)
source: ndc

Packages (1)

0006-5090-01 1 KIT in 1 CARTON (0006-5090-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

WINREVAIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "7246eda1-3e73-4bcd-8e5e-9da5f391cff5", "openfda": {"rxcui": ["2678937", "2678943", "2678945", "2678947", "2678948", "2678949", "2678950", "2678951"], "spl_set_id": ["21693ee2-cd23-4137-ac67-066bb3a4a9b7"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0006-5090-01)  *  1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99)  *  1 mL in 1 SYRINGE (0006-5079-89)", "package_ndc": "0006-5090-01", "marketing_start_date": "20240326"}], "brand_name": "WINREVAIR", "product_id": "0006-5090_7246eda1-3e73-4bcd-8e5e-9da5f391cff5", "dosage_form": "KIT", "product_ndc": "0006-5090", "generic_name": "SOTATERCEPT-CSRK", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WINREVAIR", "application_number": "BLA761363", "marketing_category": "BLA", "marketing_start_date": "20240326", "listing_expiration_date": "20271231"}