NDC codes

FDA NDC Directory
Product NDC (as listed)51862-890Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51862-0890Add 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
51862-890-0151862089001518620890011 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 2020
51862-890-0251862089002518620890021 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 2020
51862-890-0351862089003518620890033 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 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)
Azurette
Generic name (nonproprietary)
desogestrel/ethinyl estradiol and ethinyl estradiol
Dosage form
Kit
Labeler
Mayne Pharma Inc.NDC labeler code 51862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091247
Marketing start
Listing expires
Identifiers
Product ID 51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fbSPL ID 0f94b0b9-a7da-4030-9acf-542d6607d7fbSPL set ID bff09a7b-aea6-460b-a263-44576e00f510RxCUI 248310, 249357, 748797, 759743, 831872

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

N451862089001 followed by a unit qualifier and the quantity

Package 51862-0890-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II 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 these methods can result in lower failure rates. TABLE II : Percentage of women experiencing an unintended pregnancy during the first year of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-890

What is NDC 51862-890?
51862-890 is the product NDC for Azurette kit, listed with the FDA by Mayne Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Azurette (Desogestrel/ethinyl estradiol and ethinyl estradiol).
Who is the labeler?
Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azurette?
1 other product NDC are listed under this name. See all Azurette NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Azurette NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Azurettedesogestrel/ethinyl estradiol and ethinyl estradiol—KitDr. Reddys Laboratories Inc.75907-09175907-0091-2875907-0091-62

Other NDCs under ANDA 091247

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

FDA NDC Directory listings under ANDA 091247
ProductStrengthForm · routeLabelerProduct NDC
Azurettedesogestrel/ethinyl estradiol and ethinyl estradiol—KitDr. Reddys Laboratories Inc.75907-091
Pimtreadesogestrel/ethinyl estradiol and ethinyl estradiol—KitNorthstar Rx LLC16714-404

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