Prescription drug · ANDA
Aubra EQ (Levonorgestrel and ethinyl estradiol) NDC 63629-5651
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Aubra EQ
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206886
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-5651_d8c27882-7acf-4dbe-9e7b-cd25b960bfc6SPL ID d8c27882-7acf-4dbe-9e7b-cd25b960bfc6SPL set ID 5bebc7e2-d085-410c-bae1-7d758d3c2016RxCUI 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Afirmelle 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 Perfe…
Excerpt only. Read the full label for complete information.
About NDC 63629-5651
- What is NDC 63629-5651?
- 63629-5651 is the product NDC for Aubra EQ kit, listed with the FDA by Bryant Ranch Prepack.
- What drug is associated with this NDC?
- Aubra EQ (Levonorgestrel and Ethinyl Estradiol).
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aubra EQ?
- 1 other product NDC are listed under this name. See all Aubra EQ NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aubra EQ products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aubra EQlevonorgestrel and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-220 | 50102-0220-23 |
Other NDCs under ANDA 206886
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 |
|---|---|---|---|---|
| Afirmellelevonorgestrel and ethinyl estradiol | — | Kit | Aurobindo Pharma Limited | 65862-849 |
| Aubra EQlevonorgestrel and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-220 |