NDC 58468-0030

Thyrogen

Thyrotropin Alfa

Thyrogen is a Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Thyrotropin Alfa.

• Product ID: 58468-0030_4decee69-2b22-462f-a15c-7bc76248604d
• NDC: 58468-0030
• Product Type: Human Prescription Drug
• Proprietary Name: Thyrogen
• Generic Name: Thyrotropin Alfa
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 1998-11-30
• Marketing Category: BLA / NDA
• Application Number: BLA020898
• Labeler Name: Genzyme Corporation
• Substance Name: THYROTROPIN ALFA
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Thyroid Stimulating Hormone [EPC],Thyrotropin [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58468-0030-2

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

• Marketing Start Date: 1998-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0030-2 [58468003002]

Thyrogen INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA020898
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-11-30

NDC 58468-0030-1 [58468003001]

Thyrogen INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA020898
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-03-25

Drug Details

Active Ingredients

Ingredient	Strength
THYROTROPIN ALFA	.9 mg/mL

OpenFDA Data

• SPL SET ID: b52dfa36-f90b-4e19-9b5e-26db9d04df2b
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • AVX3D5A4LM

Pharmacological Class

• Thyroid Stimulating Hormone [EPC]
• Thyrotropin [CS]

NDC Crossover Matching brand name "Thyrogen" or generic name "Thyrotropin Alfa"

NDC	Brand Name	Generic Name
58468-0030	Thyrogen	THYROTROPIN ALFA
58468-1849	Thyrogen	THYROTROPIN ALFA