NDC 0173-0867

Tanzeum

Albiglutide

Tanzeum is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Albiglutide.

• Product ID: 0173-0867_547b7089-3a91-4bb4-8881-e1abfbe39e82
• NDC: 0173-0867
• Product Type: Human Prescription Drug
• Proprietary Name: Tanzeum
• Generic Name: Albiglutide
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2020-08-31
• Marketing Category: BLA / BLA
• Application Number: BLA125431
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: ALBIGLUTIDE
• Active Ingredient Strength: 50 mg/.5mL
• Pharm Classes: Glucagon-like Peptide-1 (GLP-1) Agonists [MoA],GLP-1 Receptor Agonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0173-0867-02

1 SYRINGE in 1 CARTON (0173-0867-02) > .5 mL in 1 SYRINGE

• Marketing Start Date: 2014-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0867-35 [00173086735]

Tanzeum INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125431
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2020-08-31

NDC 0173-0867-02 [00173086702]

Tanzeum INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125431
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-15
• Marketing End Date: 2019-07-31

NDC 0173-0867-01 [00173086701]

Tanzeum INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125431
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-27
• Marketing End Date: 2020-08-31

NDC 0173-0867-61 [00173086761]

Tanzeum INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125431
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-05-29
• Marketing End Date: 2019-08-31

Drug Details

Active Ingredients

Ingredient	Strength
ALBIGLUTIDE	50 mg/.5mL

OpenFDA Data

• SPL SET ID: 5fcad939-76e7-49cf-af94-4e6aef17901f
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 5E7U48495E
• RxNorm Concept Unique ID - RxCUI:
  • 1534820
  • 1534800
  • 1534822
  • 1534805

Pharmacological Class

• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
• GLP-1 Receptor Agonist [EPC]
• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
• GLP-1 Receptor Agonist [EPC]

NDC Crossover Matching brand name "Tanzeum" or generic name "Albiglutide"

NDC	Brand Name	Generic Name
0173-0866	Tanzeum	albiglutide
0173-0867	Tanzeum	albiglutide