NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1395Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1395Add 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
50090-1395-0500901395001 KIT in 1 KIT (50090-1395-0)Marketed from Nov 28, 2014

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Viorele
Generic name (nonproprietary)
desogestrel and ethinyl estradiol and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091346
Marketing start
Listing expires
Identifiers
Product ID 50090-1395_5fa87371-f59b-4042-995f-ea88f04246c1SPL ID 5fa87371-f59b-4042-995f-ea88f04246c1SPL set ID 6422dcc3-959a-4590-9ca8-9dcb58e68253RxCUI 248310, 249357, 748797, 759743, 1252016

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

N450090139500 followed by a unit qualifier and the quantity

Package 50090-1395-00. 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 . This label includes a boxed warning.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091346

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

FDA NDC Directory listings under ANDA 091346
ProductStrengthForm · routeLabelerProduct NDC
Vioreledesogestrel and ethinyl estradiol and ethinyl estradiol—KitGlenmark Pharmaceuticals Inc., USA68462-318

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