Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate NDC 69238-1686
Kit · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1686-3 | 69238168603 | 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACKMarketed from Jul 26, 2021 |
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)
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214292
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1686_90aeeab4-172c-4f1d-932e-5f543c066dbaSPL ID 90aeeab4-172c-4f1d-932e-5f543c066dbaSPL set ID e145ebc7-b6c0-474b-a712-c6f3b2342998RxCUI 1421459, 1421460, 1421461UPC 0369238168631
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
N469238168603followed by a unit qualifier and the quantityPackage 69238-1686-03. 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)
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. -------------INDICATIONS AND USAGE------------- Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1) Norethindrone acetate an…
Excerpt only. Read the full label for complete information.