intrarosa

Generic: prasterone

Labeler: millicent us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name intrarosa
Generic Name prasterone
Labeler millicent us, inc.
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

prasterone 6.5 mg/1

Manufacturer
Millicent US, Inc.

Identifiers & Regulatory

Product NDC 72495-501
Product ID 72495-501_2b9876fb-e9e0-4dbc-e063-6294a90a8696
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208470
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72495501
Hyphenated Format 72495-501

Supplemental Identifiers

RxCUI
1927688 1927693
UPC
0372495401281
UNII
459AG36T1B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name intrarosa (source: ndc)
Generic Name prasterone (source: ndc)
Application Number NDA208470 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 6.5 mg/1
source: ndc
Packaging
  • 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
source: ndc

Packages (1)

72495-501-14 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK

Ingredients (1)

prasterone (6.5 mg/1)

Linked Drug Pages (1)

Intrarosa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "2b9876fb-e9e0-4dbc-e063-6294a90a8696", "openfda": {"upc": ["0372495401281"], "unii": ["459AG36T1B"], "rxcui": ["1927688", "1927693"], "spl_set_id": ["ada639d4-bac0-2ad0-e053-2a95a90afce7"], "manufacturer_name": ["Millicent US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOX in 1 BOX (72495-501-14)  / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK", "package_ndc": "72495-501-14", "marketing_start_date": "20201101"}], "brand_name": "Intrarosa", "product_id": "72495-501_2b9876fb-e9e0-4dbc-e063-6294a90a8696", "dosage_form": "INSERT", "product_ndc": "72495-501", "generic_name": "Prasterone", "labeler_name": "Millicent US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Intrarosa", "active_ingredients": [{"name": "PRASTERONE", "strength": "6.5 mg/1"}], "application_number": "NDA208470", "marketing_category": "NDA", "marketing_start_date": "20201101", "listing_expiration_date": "20261231"}