NDC codes

FDA NDC Directory
Product NDC (as listed)68462-637Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0637Add 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
68462-637-29684620637293 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 9, 2015

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)
Levonorgestrel and Ethinyl Estradiol
Generic name (nonproprietary)
levonorgestrel and ethinyl estradiol
Active ingredients
Levonorgestrel — 90 ug/1Ethinyl estradiol — 20 ug/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202791
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers
Product ID 68462-637_ed921f2c-7961-477a-bbac-2e666d32e3baSPL ID ed921f2c-7961-477a-bbac-2e666d32e3baSPL set ID 44fbc5ae-5682-471f-a12a-955e8b4d233aRxCUI 722152, 751553UNII 5W7SIA7YZW, 423D2T571UUPC 0368462637296, 0368462637845
Pharmacologic class
Estrogen; Progestin; Progestin-containing Intrauterine System

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

N468462063729 followed by a unit qualifier and the quantity

Package 68462-0637-29. 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 Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Ty…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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