Aviane NDC 0555-9045

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-9045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-9045Add 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 NDC	11-digit (billing)	Package	Copy
0555-9045-58	00555904558	6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACKMarketed from Apr 2, 2001

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075796
Marketing start: Apr 2, 2001
Listing expires: Dec 31, 2026
Identifiers: Product ID 0555-9045_78285da7-bc34-478b-8393-c944dc5a1e02SPL ID 78285da7-bc34-478b-8393-c944dc5a1e02SPL set ID 8f88b17a-5d0e-448a-8a60-f49c28ba6dfbRxCUI 242297, 748797, 748868, 750268UPC 0305559045589

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

N400555904558 followed by a unit qualifier and the quantity

Package 00555-9045-58. 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 Jul 29, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Aviane (levonorgestrel and ethinyl estradiol tablets) in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cyc…

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
Product	Strength	Form · route	Labeler	Product NDC
Avianelevonorgestrel and ethinyl estradiol	—	Kit	Proficient Rx LP	63187-889