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NDC 72495-0501-14 Intrarosa 6.5 mg/1 Details
Intrarosa 6.5 mg/1
Intrarosa is a VAGINAL INSERT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Millicent US, Inc.. The primary component is PRASTERONE.
MedlinePlus Drug Summary
Vaginal prasterone is used to treat changes in and around the vagina due to menopause ("change of life," the end of monthly menstrual periods) that can cause painful sexual intercourse. Prasterone is in a class of medications called steroids. It works by replacing hormones that are normally produced in the body.
Related Packages: 72495-0501-14Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Prasterone Vaginal
Product Information
| NDC | 72495-0501 |
|---|---|
| Product ID | 72495-501_f277c0eb-453c-8d7d-e053-2995a90a20df |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Intrarosa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Prasterone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INSERT |
| Route | VAGINAL |
| Active Ingredient Strength | 6.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | PRASTERONE |
| Labeler Name | Millicent US, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208470 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72495-0501-14 (72495050114)
| NDC Package Code | 72495-501-14 |
|---|---|
| Billing NDC | 72495050114 |
| Package | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK |
| Marketing Start Date | 2020-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |