NDC 64011-301

Makena

Hydroxyprogesterone Caproate

Makena is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Hydroxyprogesterone Caproate.

• Product ID: 64011-301_2586f54d-3cef-46fe-b5e8-1dc9a9861ee3
• NDC: 64011-301
• Product Type: Human Prescription Drug
• Proprietary Name: Makena
• Generic Name: Hydroxyprogesterone Caproate
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-02-14
• Marketing Category: NDA / NDA
• Application Number: NDA021945
• Labeler Name: AMAG Pharmaceuticals, Inc.
• Substance Name: HYDROXYPROGESTERONE CAPROATE
• Active Ingredient Strength: 250 mg/mL
• Pharm Classes: Progesterone Congeners [CS], Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 64011-301-03

1 SYRINGE in 1 CARTON (64011-301-03) > 1.1 mL in 1 SYRINGE

• Marketing Start Date: 2018-02-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64011-301-03 [64011030103]

Makena INJECTION

• Marketing Category: NDA
• Application Number: NDA021945
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-14

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYPROGESTERONE CAPROATE	250 mg/mL

OpenFDA Data

• SPL SET ID: a1998c1d-8337-4f00-8dcb-af3b54d39b77
• Manufacturer:
  • AMAG Pharmaceuticals, Inc.
• UNII:
  • 276F2O42F5
• RxNorm Concept Unique ID - RxCUI:
  • 2000013
  • 2000011
  • 1087968
  • 1087964
  • 1796690
  • 1796692
• UPC Code:
  • 0364011247022
  • 0364011243017

Pharmacological Class

• Progesterone Congeners [CS]
• Progestin [EPC]
• Progesterone Congeners [CS]
• Progestin [EPC]

NDC Crossover Matching brand name "Makena" or generic name "Hydroxyprogesterone Caproate"

NDC	Brand Name	Generic Name
64011-243	Makena	hydroxyprogesterone caproate
64011-247	Makena	hydroxyprogesterone caproate
64011-301	Makena	hydroxyprogesterone caproate
0517-1767	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
0517-1791	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
47335-037	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE
55150-309	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE
55150-310	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE
55150-311	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
66993-038	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate
66993-039	Hydroxyprogesterone Caproate	hydroxyprogesterone caproate
67457-886	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
67457-967	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
69238-1797	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate
71225-104	HYDROXYPROGESTERONE CAPROATE	HYDROXYPROGESTERONE CAPROATE
71225-105	Hydroxyprogesterone caproate	Hydroxyprogesterone caproate
73301-001	Hydroxyprogesterone Caproate	Hydroxyprogesterone Caproate