NDC 64011-601

Intrarosa

Prasterone

Intrarosa is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Prasterone.

• Product ID: 64011-601_39aae199-bf1a-471d-801a-b1b297b2b8a0
• NDC: 64011-601
• Product Type: Human Prescription Drug
• Proprietary Name: Intrarosa
• Generic Name: Prasterone
• Dosage Form: Insert
• Route of Administration: VAGINAL
• Marketing Start Date: 2017-06-06
• Marketing Category: NDA / NDA
• Application Number: NDA208470
• Labeler Name: AMAG Pharmaceuticals, Inc.
• Substance Name: PRASTERONE
• Active Ingredient Strength: 7 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64011-601-14

1 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK

• Marketing Start Date: 2017-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64011-601-28 [64011060128]

Intrarosa INSERT

• Marketing Category: NDA
• Application Number: NDA208470
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-06

NDC 64011-601-14 [64011060114]

Intrarosa INSERT

• Marketing Category: NDA
• Application Number: NDA208470
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-06

Drug Details

Active Ingredients

Ingredient	Strength
PRASTERONE	6.5 mg/1

OpenFDA Data

• SPL SET ID: df731acd-7276-4fef-b037-bc7f30c112cb
• Manufacturer:
  • AMAG Pharmaceuticals, Inc.
• UNII:
  • 459AG36T1B
• RxNorm Concept Unique ID - RxCUI:
  • 1927688
  • 1927693

Medicade Reported Pricing

64011060128 INTRAROSA 6.5 MG VAG INSERT

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Intrarosa" or generic name "Prasterone"

NDC	Brand Name	Generic Name
64011-601	Intrarosa	Prasterone
72495-401	Intrarosa	Prasterone
72495-501	Intrarosa	Prasterone
63776-653	DHEA	Prasterone