Prescription drug · NDA
Intrarosa (Prasterone) NDC 72495-501
Prasterone 6.5 mg/1 · Insert · Vaginal · Millicent US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72495-501-14 | 7249505011472495050114 | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACKMarketed from Nov 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Intrarosa
- Generic name (nonproprietary)
- prasterone
- Active ingredients
- Prasterone — 6.5 mg/1
- Dosage form
- Insert
- Route
- Vaginal
- Labeler
- Millicent US, Inc.NDC labeler code 72495
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208470
- Marketing start
- Listing expires
- Identifiers
- Product ID 72495-501_35d8836d-d828-4c04-903d-521c6abf9c42SPL ID 35d8836d-d828-4c04-903d-521c6abf9c42SPL set ID ada639d4-bac0-2ad0-e053-2a95a90afce7RxCUI 1927688, 1927693UNII 459AG36T1B
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N472495050114followed by a unit qualifier and the quantityPackage 72495-0501-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 72495-501
- What is NDC 72495-501?
- 72495-501 is the product NDC for Intrarosa (prasterone), Prasterone 6.5 mg/1 insert, listed with the FDA by Millicent US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Intrarosa (Prasterone).
- What is the active ingredient?
- Prasterone.
- Who is the labeler?
- Millicent US, Inc., NDC labeler code 72495. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Intrarosa?
- 1 other product NDC are listed under this name. See all Intrarosa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Intrarosa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Intrarosaprasterone | Prasterone 6.5 mg/1 | InsertVaginal | Millicent US, Inc. | 72495-401 | 72495-0401-28 |
Other NDCs under NDA 208470
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Intrarosaprasterone | Prasterone 6.5 mg/1 | InsertVaginal | Millicent US, Inc. | 72495-401 |