Prescription drug · ANDA
Estarylla (Norgestimate and ethinyl estradiol) NDC 82804-158
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-158-28 | 82804015828 | 1 BLISTER PACK in 1 POUCH (82804-158-28) / 1 KIT in 1 BLISTER PACKMarketed from Oct 7, 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)
- Estarylla
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090794
- Marketing start
- Listing expires
- Identifiers
- Product ID 82804-158_7acde5ef-f457-4c47-897b-d048194c7d7eSPL ID 7acde5ef-f457-4c47-897b-d048194c7d7eSPL set ID 7acde5ef-f457-4c47-897b-d048194c7d7eRxCUI 240128, 748797, 749860, 1369737UPC 0382804158287
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
N482804015828followed by a unit qualifier and the quantityPackage 82804-0158-28. 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)
Estarylla (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( Error! Hyperlink reference not valid. ) 1.1 Oral Contraceptive Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ] .
Excerpt only. Read the full label for complete information.
About NDC 82804-158
- What is NDC 82804-158?
- 82804-158 is the product NDC for Estarylla kit, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estarylla (Norgestimate and ethinyl estradiol).
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estarylla?
- 2 other product NDCs are listed under this name. See all Estarylla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estarylla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Bryant Ranch Prepack | 63629-2349 | — |
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-119 | 70700-0119-85 |
Other NDCs under ANDA 090794
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Bryant Ranch Prepack | 63629-2349 |
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-119 |
| Norgestimate and Ethinyl Estradiol | — | Kit | AvKARE | 42291-553 |