NDC codes

FDA NDC Directory
Product NDC (as listed)65862-939Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0939Add 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 NDC11-digit (billing)PackageCopy
65862-939-5465862093954658620939545 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2017
65862-939-8865862093988658620939883 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 LimitedNDC labeler code 65862
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

N465862093954 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 65862-939

What is NDC 65862-939?
65862-939 is the product NDC for Aurovela 1/20, Norethindrone acetate 1 mg/1; Ethinyl estradiol 20 ug/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aurovela 1/20 (Norethindrone Acetate and Ethinyl Estradiol).
What is the active ingredient?
Norethindrone acetate, Ethinyl estradiol.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aurovela 1/20?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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