Aurovela 1.5/30 NDC 65862-935

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-935Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0935Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65862-935-54	65862093554	5 POUCH in 1 CARTON (65862-935-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Jun 26, 2017
65862-935-74	65862093574	3 POUCH in 1 CARTON (65862-935-74) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Jun 26, 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 1.5/30
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol
Active ingredients: Norethindrone acetate — 1.5 mg/1Ethinyl estradiol — 30 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 207581
Marketing start: Jun 26, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 65862-935_07926174-446c-43dc-9db1-db8b78432645SPL ID 07926174-446c-43dc-9db1-db8b78432645SPL set ID b146e49c-a0fc-4f3d-9ad6-99e8257fa139RxCUI 1359022, 1359028, 1928007UNII 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

N465862093554 followed by a unit qualifier and the quantity

Package 65862-0935-54. 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 Nov 21, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Aurovela 1.5/30 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.

Full label on DailyMed (opens in a new tab)