Prescription drug · ANDA
Estradiol NDC 63629-8804
Estradiol 10 ug/1 · Insert · Vaginal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8804-1 | 63629880401 | 18 BLISTER PACK in 1 CARTON (63629-8804-1) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATORMarketed from Sep 10, 2021 |
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 — 10 ug/1
- Dosage form
- Insert
- Route
- Vaginal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206388
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-8804_b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020SPL ID b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020SPL set ID d9514497-6b9e-4c13-950b-6b036ff101c1RxCUI 884707UNII 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 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
N463629880401followed by a unit qualifier and the quantityPackage 63629-8804-01. 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 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.
Other NDCs under ANDA 206388
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.