Prescription drug · ANDA

Estradiol NDC 72162-2290

Estradiol .25 mg/.25g · Gel · Topical · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2290Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2290Add 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
72162-2290-37216222900330 PACKET in 1 CARTON (72162-2290-3) / .25 g in 1 PACKETMarketed from Apr 30, 2024

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 — .25 mg/.25g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216524
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 72162-2290_df474224-ce8c-4240-a409-77cc4259a103SPL ID df474224-ce8c-4240-a409-77cc4259a103SPL set ID e6bf2abc-71ae-4e79-a37b-164c98ba746aRxCUI 2619677UNII 4TI98Z838E
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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472162229003 followed by a unit qualifier and the quantity

Package 72162-2290-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol gel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ). 1.1 Treatment of Moderate to Severe Vasomotor Symptoms 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 216524

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

FDA NDC Directory listings under ANDA 216524
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .5 mg/.5gGelTopicalBryant Ranch Prepack72162-2291
EstradiolEstradiol .75 mg/.75gGelTopicalBryant Ranch Prepack72162-2292
EstradiolEstradiol 1 mg/gGelTopicalBryant Ranch Prepack72162-2293
EstradiolEstradiol .25 mg/.25gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-134
EstradiolEstradiol .5 mg/.5gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-202
EstradiolEstradiol .75 mg/.75gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-310
EstradiolEstradiol 1 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-452
EstradiolEstradiol 1.25 mg/1.25gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-573

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