What is NDC 65862-934?

65862-934 is the product NDC for Aurovela 24 Fe kit, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Aurovela 24 Fe (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate).

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 24 Fe?

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.

Aurovela 24 Fe NDC 65862-934 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-934Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0934Add 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
65862-934-58	6586209345865862093458	5 POUCH in 1 CARTON (65862-934-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Jun 15, 2017
65862-934-87	6586209348765862093487	1 POUCH in 1 CARTON (65862-934-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Jun 15, 2017
65862-934-88	6586209348865862093488	3 POUCH in 1 CARTON (65862-934-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Jun 15, 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 24 Fe
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form: Kit
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207504
Marketing start: Jun 15, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aedSPL ID 8b98eb73-94c9-43f2-bc65-de59a5ed1aedSPL set ID 3eb092dc-2ec1-4d55-b1fe-69505608e04aRxCUI 259176, 1358762, 1359117, 1927957

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

N465862093458 followed by a unit qualifier and the quantity

Package 65862-0934-58. 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)

Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Aurovela 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. ( 1 , 8.8 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-934

What is NDC 65862-934?: 65862-934 is the product NDC for Aurovela 24 Fe kit, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Aurovela 24 Fe (Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate).
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 24 Fe?: 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.

Other NDCs under ANDA 207504

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207504
Product	Strength	Form · route	Labeler	Product NDC
Tarina 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate	—	Kit	Afaxys Pharma, LLC	50102-224