Prescription drug · ANDA
Aviane (Levonorgestrel and ethinyl estradiol) NDC 63187-889
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-889-28 | 6318708892863187088928 | 1 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
- Labeler
- Proficient Rx LPNDC labeler code 63187
- 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
N463187088928followed by a unit qualifier and the quantityPackage 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.
About NDC 63187-889
- What is NDC 63187-889?
- 63187-889 is the product NDC for Aviane kit, listed with the FDA by Proficient Rx LP. 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?
- Proficient Rx LP, NDC labeler code 63187. 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 | Teva Pharmaceuticals USA, Inc. | 0555-9045 | 00555-9045-58 |
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 | Teva Pharmaceuticals USA, Inc. | 0555-9045 |