Prescription drug · NDA
EstroGel (estradiol) NDC 17139-617
Estradiol .75 mg/1.25g · Gel, Metered · Topical · ASCEND Therapeutics US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17139-617-40 | 17139061740 | 50 g in 1 BOTTLE, PUMP (17139-617-40)Marketed from Feb 9, 2004 |
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)
- EstroGel
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .75 mg/1.25g
- Dosage form
- Gel, Metered
- Route
- Topical
- Labeler
- ASCEND Therapeutics US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021166
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 17139-617_55240d4b-c38e-43ed-9d58-a9f5d453d2c2SPL ID 55240d4b-c38e-43ed-9d58-a9f5d453d2c2SPL set ID 762ac371-bb8b-47e7-b48f-e80d452c9dd4RxCUI 226597, 581549UNII 4TI98Z838EUPC 0317139617406
- 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
N417139061740followed by a unit qualifier and the quantityPackage 17139-0617-40. 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)
EstroGel 0.06% is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Excerpt only. Read the full label for complete information.
- openFDA data updated
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