Prescription drug · ANDA
Reclipsen 28 Day NDC 0093-3304
desogestrel and ethinyl estradiol · Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3304-16 | 00093330416 | 6 POUCH in 1 CARTON (0093-3304-16) / 1 BLISTER PACK in 1 POUCH (0093-3304-28) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Reclipsen 28 DaySuffix: 28 Day
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075256
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-3304_6b24007e-0560-443d-9bca-894487c931afSPL ID 6b24007e-0560-443d-9bca-894487c931afSPL set ID a1e00bc6-7487-4057-9dcc-d0e2327d1d12RxCUI 240707, 748797, 749848, 753543
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
N400093330416followed by a unit qualifier and the quantityPackage 00093-3304-16. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 075256
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 |
|---|---|---|---|---|
| Apri 28 Daydesogestrel and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9043 |
| Apri 28 Daydesogestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2481 |