Prescription drug · ANDA
HAILEY Fe 1/20 NDC 68462-419
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 |
|---|---|---|---|
| 68462-419-29 | 68462041929 | 3 BLISTER PACK in 1 CARTON (68462-419-29) / 1 KIT in 1 BLISTER PACK (68462-419-84)Marketed from Nov 21, 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 Fe 1/20
- 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 206597
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-419_feb1bb19-095f-41f5-8e21-f291bec04d25SPL ID feb1bb19-095f-41f5-8e21-f291bec04d25SPL set ID 72bd59e6-26cb-4c01-9511-586372b768b2RxCUI 259176, 1358762, 1358763, 1989873UPC 0368462419298
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
N468462041929followed by a unit qualifier and the quantityPackage 68462-0419-29. 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)
INDICATIONS AND USAGE Hailey Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Adapted from RA Hatcher et al, Reference 7. * The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate …
Excerpt only. Read the full label for complete information.