Prescription drug · ANDA
Affodel (norethindrone) NDC 79929-015
Norethindrone .35 mg/1 · Tablet · Oral · Naari Pte. Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79929-015-07 | 79929001507 | 84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACKMarketed from May 31, 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)
- Affodel
- Generic name (nonproprietary)
- norethindrone
- Active ingredients
- Norethindrone — .35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Naari Pte. Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206807
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4SPL ID 16aaf795-d546-9f9c-e063-6394a90a09c4SPL set ID 8ec64ec8-fbc9-440d-9838-654a605d57daRxCUI 198042, 748961UNII 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
N479929001507followed by a unit qualifier and the quantityPackage 79929-0015-07. 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 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: 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. % of Women Experiencing an Unintended Pregnancy…
Excerpt only. Read the full label for complete information.