Prescription drug · ANDA
Xarah Fe NDC 70700-310
norethindrone acetate and ethinyl estradiol and ferrous fumarate tablets · Kit · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-310-85 | 70700031085 | 3 POUCH in 1 CARTON (70700-310-85) / 1 BLISTER PACK in 1 POUCH (70700-310-84) / 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)
- Xarah Fe
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate tablets
- Dosage form
- Kit
- Labeler
- Xiromed LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205069
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-310_817ee8b8-f24d-0dfd-e969-2f5ef8d8cbb8SPL ID 817ee8b8-f24d-0dfd-e969-2f5ef8d8cbb8SPL set ID 2c5cf9c3-948e-964b-7424-21c84461df93RxCUI 259176, 1358762, 1359130, 1359131, 1359132, 2703554
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
N470700031085followed by a unit qualifier and the quantityPackage 70700-0310-85. 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)
INDICATIONS AND USAGE Xarah Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Xarah Fe is indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Xarah Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lis…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205069
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 |
|---|---|---|---|---|
| Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7303 |