Prescription drug · ANDA
Hailey 24 Fe NDC 68462-731
norethindrone acetate and ethinyl estradiol, and ferrous fumarate · Kit · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-731-29 | 68462073129 | 3 BLISTER PACK in 1 CARTON (68462-731-29) / 1 KIT in 1 BLISTER PACK (68462-731-84)Marketed from Nov 17, 2017 |
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)
- Hailey 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 204847
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-731_12f7a9d2-4627-40c2-987f-202a9aad27deSPL ID 12f7a9d2-4627-40c2-987f-202a9aad27deSPL set ID ab399c1c-5613-4e7d-88f7-ec41533d4da3RxCUI 259176, 1358762, 1359117, 1989507UPC 0368462731291, 0368462731840
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
N468462073129followed by a unit qualifier and the quantityPackage 68462-0731-29. 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)
Hailey 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies ( 14 )]. The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Hailey 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.