Prescription drug · ANDA
Aurovela 1/20 NDC 65862-939
norethindrone acetate and ethinyl estradiol · Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-939-54 | 65862093954 | 5 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2017 | |
| 65862-939-88 | 65862093988 | 3 POUCH in 1 CARTON (65862-939-88) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Jun 16, 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)
- Aurovela 1/20
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Active ingredients
- Norethindrone acetate — 1 mg/1Ethinyl estradiol — 20 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207506
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 65862-939_e42c0b14-e08a-4e77-8ead-8b44fb472f5fSPL ID e42c0b14-e08a-4e77-8ead-8b44fb472f5fSPL set ID 6765becf-7b51-4f33-ac13-70fcd01decf7RxCUI 1358762, 1358776, 1927366UNII 9S44LIC7OJ, 423D2T571U
- Pharmacologic class
- Estrogen; Progestin
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465862093954followed by a unit qualifier and the quantityPackage 65862-0939-54. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Aurovela 1/20 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 I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. * The authors’ best guess …
Excerpt only. Read the full label for complete information.