NDC codes

FDA NDC Directory
Product NDC (as listed)72495-501Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72495-0501Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72495-501-14724950501141 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
Prasterone6.5 mg/1
Dosage form
Insert
Route
Vaginal
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

N472495050114 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208470

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208470
ProductStrengthForm · routeLabelerProduct NDC
IntrarosaprasteronePrasterone 6.5 mg/1InsertVaginalMillicent US, Inc.72495-401

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