Desogestrel and Ethinyl Estradiol NDC 51862-514

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0514Add 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
51862-514-01	51862051401	1 BLISTER PACK in 1 PACKET (51862-514-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 4, 2020
51862-514-02	51862051402	1 BLISTER PACK in 1 CARTON (51862-514-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 4, 2020
51862-514-03	51862051403	3 BLISTER PACK in 1 CARTON (51862-514-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 4, 2020
51862-514-06	51862051406	6 BLISTER PACK in 1 CARTON (51862-514-06) / 1 KIT in 1 BLISTER PACKMarketed from Oct 4, 2020

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): Desogestrel and Ethinyl Estradiol
Generic name (nonproprietary): desogestrel and ethinyl estradiol
Dosage form: Kit
Labeler: Mayne Pharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091234
Marketing start: Oct 4, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 51862-514_9d1ee9ee-0e36-4055-9b6e-2445bc713cabSPL ID 9d1ee9ee-0e36-4055-9b6e-2445bc713cabSPL set ID 198477e0-855a-4a1d-ae0b-407568dd05f8RxCUI 240707, 748797, 749848

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

N451862051401 followed by a unit qualifier and the quantity

Package 51862-0514-01. 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 Dec 8, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Desogestrel and ethinyl estradiol tablets, USP are 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 combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cyc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091234

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

FDA NDC Directory listings under ANDA 091234
Product	Strength	Form · route	Labeler	Product NDC
Juleberdesogestrel and ethinyl estradiol	—	Kit	Northstar Rx LLC	16714-464