thyrogen

Generic: thyrotropin alfa

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name thyrogen
Generic Name thyrotropin alfa
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

thyrotropin alfa .9 mg/mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0030
Product ID 58468-0030_a62de867-ea60-47eb-873a-788223a1181f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA020898
Listing Expiration 2026-12-31
Marketing Start 1998-11-30

Pharmacologic Class

Established (EPC)
thyroid stimulating hormone [epc]
Chemical Structure
thyrotropin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680030
Hyphenated Format 58468-0030

Supplemental Identifiers

RxCUI
2166572 2166573 2166578 2166579 2554801 2554802 2554804 2554805
UNII
AVX3D5A4LM
NUI
N0000175949 M0021496

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 thyrogen (source: ndc)
Generic Name thyrotropin alfa (source: ndc)
Application Number BLA020898 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • .9 mg/mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1)
source: ndc

Packages (1)

58468-0030-2 2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1)

Ingredients (1)

thyrotropin alfa (.9 mg/mL)

Linked Drug Pages (1)

Thyrogen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "a62de867-ea60-47eb-873a-788223a1181f", "openfda": {"nui": ["N0000175949", "M0021496"], "unii": ["AVX3D5A4LM"], "rxcui": ["2166572", "2166573", "2166578", "2166579", "2554801", "2554802", "2554804", "2554805"], "spl_set_id": ["b52dfa36-f90b-4e19-9b5e-26db9d04df2b"], "pharm_class_cs": ["Thyrotropin [CS]"], "pharm_class_epc": ["Thyroid Stimulating Hormone [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2)  / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1)", "package_ndc": "58468-0030-2", "marketing_start_date": "19981130"}], "brand_name": "Thyrogen", "product_id": "58468-0030_a62de867-ea60-47eb-873a-788223a1181f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroid Stimulating Hormone [EPC]", "Thyrotropin [CS]"], "product_ndc": "58468-0030", "generic_name": "THYROTROPIN ALFA", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thyrogen", "active_ingredients": [{"name": "THYROTROPIN ALFA", "strength": ".9 mg/mL"}], "application_number": "BLA020898", "marketing_category": "BLA", "marketing_start_date": "19981130", "listing_expiration_date": "20261231"}