Intrarosa
- Product NDC
- 72495-401
- 11-digit product format
- 724950401
- Labeler code
- 72495
- Product ID
- 72495-401_2b9876fb-e9e0-4dbc-e063-6294a90a8696
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prasterone
- Dosage form
- INSERT
- Route
- VAGINAL
- Labeler
- Millicent US, Inc.
- Application
- NDA208470
- Marketing category
- NDA
- Marketing start
- 2020-11-01
- Substance
- PRASTERONE
- Active strength
- 6.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Intrarosa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRASTERONE | 6.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459AG36T1B |
| Rxcui | 1927688, 1927693 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72495-401-28 | Intrarosa | 1 in 1 BOX | INSERT | 1 | | 5 |
| 72495-401-28 | Intrarosa | 28 in 1 BOX | INSERT | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72495-401 | INTRAROSA (PRASTERONE) INSERT [MILLICENT US, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250114_ada639d4-bac0-2ad0-e053-2a95a90afce7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72495-401-28 | 72495040128 | 1 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 1 box | 2020-11-01 | 0000-00-00 | No | No | Current |