Estradiol NDC 50090-3645

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-3645Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-3645Add 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
50090-3645-0	50090364500	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-3645-0) / 42.5 g in 1 TUBE, WITH APPLICATORMarketed from Oct 10, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol hemihydrate — .1 mg/g
Dosage form: Cream
Route: Vaginal
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209767
Marketing start: Mar 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 50090-3645_12285983-0127-4a9f-9fcd-ee4b97115f09SPL ID 12285983-0127-4a9f-9fcd-ee4b97115f09SPL set ID 31646359-292c-4bca-88a4-7a89b11c3f44RxCUI 310169UNII 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

N450090364500 followed by a unit qualifier and the quantity

Package 50090-3645-00. 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 Dec 12, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms 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)

Other NDCs under ANDA 209767

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

FDA NDC Directory listings under ANDA 209767
Product	Strength	Form · route	Labeler	Product NDC
Estradiol Vaginalestradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Encube Ethicals, Inc.	21922-085
Estradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Bryant Ranch Prepack	63629-8713
Estradiol Vaginalestradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Redpharm Drug	67296-2303
Estradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Alvogen Inc.	47781-104