NDC codes

FDA NDC Directory
Product NDC (as listed)68462-419Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0419Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68462-419-29684620419293 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

N468462041929 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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