Osphena (ospemifene) NDC 55494-580

NDC codes

FDA NDC Directory

Product NDC (as listed)55494-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55494-0580Add 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 NDC	11-digit (billing)	Package
55494-580-18	55494058018	1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2023 · Sample package
55494-580-30	55494058030	30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)Marketed from Aug 1, 2023
55494-580-55	55494058055	1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2023 · Sample package
55494-580-90	55494058090	90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)Marketed from Apr 1, 2023

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): Osphena
Generic name (nonproprietary): ospemifene
Active ingredients: Ospemifene — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Duchesnay USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203505
Marketing start: Apr 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636aSPL ID 2e1f0dd2-9e5b-413e-e063-6294a90a636aSPL set ID 9accbcc9-78ee-4f84-9b7e-704f2ab1c413RxCUI 1370976, 1370982UNII B0P231ILBK
Pharmacologic class: Estrogen Agonist/Antagonist

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455494058018 followed by a unit qualifier and the quantity

Package 55494-0580-18. 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 Feb 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.1 ) The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.2 ) 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)