Prescription drug · ANDA
Aviane (Levonorgestrel and ethinyl estradiol) NDC 0555-9045
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9045-58 | 0055590455800555904558 | 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.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075796
- Marketing start
- Listing expires
- 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
N400555904558followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 0555-9045
- What is NDC 0555-9045?
- 0555-9045 is the product NDC for Aviane kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aviane (Levonorgestrel and Ethinyl Estradiol).
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aviane?
- 1 other product NDC are listed under this name. See all Aviane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aviane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Avianelevonorgestrel and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-889 | 63187-0889-28 |
Other NDCs under ANDA 075796
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Avianelevonorgestrel and ethinyl estradiol | — | Kit | Proficient Rx LP | 63187-889 |