NDC 71090-002

Macrilen

Macimorelin Acetate

Macrilen is a Oral Granule, For Solution in the Human Prescription Drug category. It is labeled and distributed by Strongbridge U.s. Inc. The primary component is Macimorelin.

• Product ID: 71090-002_a17c00fc-7be7-423d-930d-46b152e64224
• NDC: 71090-002
• Product Type: Human Prescription Drug
• Proprietary Name: Macrilen
• Generic Name: Macimorelin Acetate
• Dosage Form: Granule, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-29
• Marketing Category: NDA / NDA
• Application Number: NDA205598
• Labeler Name: Strongbridge U.S. Inc
• Substance Name: MACIMORELIN
• Active Ingredient Strength: 60 mg/mg
• Pharm Classes: Growth Hormone Secretagogue Receptor Agonist [EPC],Growth Hormone Secretagogue Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71090-002-02

1 POUCH in 1 CARTON (71090-002-02) > 60 mg in 1 POUCH

• Marketing Start Date: 2018-01-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71090-002-02 [71090000202]

Macrilen GRANULE, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA205598
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-01-29

Drug Details

Active Ingredients

Ingredient	Strength
MACIMORELIN	60 mg/mg

OpenFDA Data

• SPL SET ID: 084e8f27-dcec-4cb0-9b37-fe0fd7f75712
• Manufacturer:
  • Strongbridge U.S. Inc
• UNII:
  • 8680B21W73

Pharmacological Class

• Growth Hormone Secretagogue Receptor Agonist [EPC]
• Growth Hormone Secretagogue Receptor Agonists [MoA]
• Growth Hormone Secretagogue Receptor Agonist [EPC]
• Growth Hormone Secretagogue Receptor Agonists [MoA]

NDC Crossover Matching brand name "Macrilen" or generic name "Macimorelin Acetate"

NDC	Brand Name	Generic Name
0169-1401	Macrilen	Macimorelin acetate
71090-002	Macrilen	Macimorelin acetate