NDC codes

FDA NDC Directory
Product NDC (as listed)63187-889Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0889Add 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
63187-889-28631870889281 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACKMarketed from Aug 1, 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)
Aviane
Generic name (nonproprietary)
levonorgestrel and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075796
Marketing start
Listing expires
Identifiers
Product ID 63187-889_8ba026e3-dc92-4a89-82db-923183c27184SPL ID 8ba026e3-dc92-4a89-82db-923183c27184SPL set ID 411e6e51-b435-4f86-b39f-3377f009b0e9RxCUI 242297, 748797, 748868, 750268UPC 0363187889289

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

N463187088928 followed by a unit qualifier and the quantity

Package 63187-0889-28. 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 Aviane (levonorgestrel and ethinyl estradiol tablets USP) 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 II 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, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYP…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075796

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075796
ProductStrengthForm · routeLabelerProduct NDC
Avianelevonorgestrel and ethinyl estradiol—KitTeva Pharmaceuticals USA, Inc.0555-9045

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