Prescription drug · ANDA
Meleya (norethindrone) NDC 70700-317
Norethindrone .35 mg/1 · Tablet · Oral · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-317-85 | 70700031785 | 3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET 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)
- Meleya
- Generic name (nonproprietary)
- norethindrone
- Active ingredients
- Norethindrone — .35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Xiromed LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200980
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38SPL ID a3bb0699-e518-4526-e81e-df5e1afefe38SPL set ID 534c5717-382c-4109-3208-e21b32e4c4c9RxCUI 198042, 748961, 2716571UNII T18F433X4S
- Pharmacologic class
- Progestin
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
N470700031785followed by a unit qualifier and the quantityPackage 70700-0317-85. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. Method (1) % of Women Experiencing an Unintended Pregnancy wi…
Excerpt only. Read the full label for complete information.