Estradiol Vaginal Inserts (estradiol) NDC 59651-439

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-439Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0439Add 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	Copy
59651-439-08	59651043908	8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Aug 2, 2024
59651-439-18	59651043918	18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Aug 2, 2024

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): Estradiol Vaginal Inserts
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol hemihydrate — 10 ug/1
Dosage form: Tablet, Film coated
Route: Vaginal
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216550
Marketing start: Aug 2, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0cSPL ID 2df3b31e-32a6-49cd-a636-5b7779a5ed0cSPL set ID 6247e329-e20e-4ea5-9cc1-b593bd494577RxCUI 884707UNII CXY7B3Q98Z
Pharmacologic class: Estrogen

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

N459651043908 followed by a unit qualifier and the quantity

Package 59651-0439-08. 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 Sep 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ) 1.1 Treatment of Atrophic Vaginitis due to Menopause .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216550

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

FDA NDC Directory listings under ANDA 216550
Product	Strength	Form · route	Labeler	Product NDC
Estradiol Vaginal Insertsestradiol	Estradiol hemihydrate 10 ug/1	Tablet, Film coatedVaginal	NorthStar Rx LLC	72603-874