Prescription drug · ANDA
Aubra EQ NDC 50102-220
levonorgestrel and ethinyl estradiol · Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-220-23 | 50102022023 | 3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACKMarketed from Nov 14, 2016 |
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)
- Aubra EQ
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Afaxys Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206886
- Marketing start
- Listing expires
- Identifiers
- Product ID 50102-220_168ba8ff-87c7-4c10-a48d-6fe29555a997SPL ID 168ba8ff-87c7-4c10-a48d-6fe29555a997SPL set ID 61207a91-8b3c-4231-b98f-3cb9f4a4be09RxCUI 242297, 748797, 748868, 1440185
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
N450102022023followed by a unit qualifier and the quantityPackage 50102-0220-23. 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 Aubra EQ 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfec…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206886
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.