Prescription drug · ANDA
Melodetta 24 Fe NDC 69238-1031
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1031-7 | 69238103107 | 3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6)Marketed from Sep 21, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Melodetta 24 Fe
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207514
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1031_ef7d6985-bc76-4ecc-9774-7edfacbef22cSPL ID ef7d6985-bc76-4ecc-9774-7edfacbef22cSPL set ID ca89a8e3-4df1-4e4b-9da7-0233770e542bRxCUI 259176, 1426288, 1426600, 1944656UPC 0369238103168, 0369238103175
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
N469238103107followed by a unit qualifier and the quantityPackage 69238-1031-07. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Melodetta™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Melodetta™ 24 Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated (1, 8.8)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207514
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 | Amneal Pharmaceuticals NY LLC | 60219-1031 |