What is NDC 65862-925?

65862-925 is the product NDC for Incassia (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

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 Incassia?

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.

Incassia NDC 65862-925 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-925Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0925Add 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
65862-925-28	65862092528	1 BLISTER PACK in 1 CARTON (65862-925-28) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 23, 2016
65862-925-85	65862092585	3 BLISTER PACK in 1 CARTON (65862-925-85) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 23, 2016
65862-925-86	65862092586	6 BLISTER PACK in 1 CARTON (65862-925-86) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 23, 2016
65862-925-87	65862092587	1 POUCH in 1 CARTON (65862-925-87) / 1 TABLET in 1 POUCHMarketed from Sep 23, 2016
65862-925-88	65862092588	3 POUCH in 1 CARTON (65862-925-88) / 1 TABLET in 1 POUCHMarketed from Sep 23, 2016
65862-925-92	65862092592	6 POUCH in 1 CARTON (65862-925-92) / 1 TABLET in 1 POUCHMarketed from Sep 23, 2016

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): Incassia
Generic name (nonproprietary): norethindrone
Active ingredients: Norethindrone — .35 mg/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 207304
Marketing start: Sep 23, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 65862-925_0caa1c4e-9536-49b0-a523-b6a6676434baSPL ID 0caa1c4e-9536-49b0-a523-b6a6676434baSPL set ID 0b87cef0-610c-469d-92ba-4007f4bc3878RxCUI 198042, 748961, 2052064UNII T18F433X4S
Pharmacologic class: 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

N465862092528 followed by a unit qualifier and the quantity

Package 65862-0925-28. 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 Sep 14, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin - only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-925

What is NDC 65862-925?: 65862-925 is the product NDC for Incassia (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Incassia (Norethindrone).
What is the active ingredient?: Norethindrone.
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 Incassia?: 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 207304

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

FDA NDC Directory listings under ANDA 207304
Product	Strength	Form · route	Labeler	Product NDC
Lyleqnorethindrone	Norethindrone .35 mg/1	TabletOral	Afaxys Pharma, LLC	50102-300

Incassia (Norethindrone) NDC 65862-925