Prescription drug · ANDA
Rosyrah NDC 70700-312
levonorgestrel and ethinyl estradiol and ethinyl estradiol · Kit · Oral · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-312-87 | 70700031287 | 1 POUCH in 1 CARTON (70700-312-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Jan 29, 2025 |
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)
- Rosyrah
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206053
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-312_4fb6f740-69bf-590d-4474-43ff5c2e5986SPL ID 4fb6f740-69bf-590d-4474-43ff5c2e5986SPL set ID d2f0af55-205f-df9c-c572-1f7b14976655RxCUI 238019, 248310, 1373501, 1373502, 1373503, 2705814UPC 0370700312872
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470700031287followed by a unit qualifier and the quantityPackage 70700-0312-87. 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)
Rosyrah is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Rosyrah is indicated for use by females of reproductive age to prevent pregnancy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206053
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 |
|---|---|---|---|---|
| Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7316 |