NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4881Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4881Add 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
50090-4881-0500904881001 KIT in 1 KIT (50090-4881-0)Marketed from Feb 11, 2020

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)
Mono-Linyah
Generic name (nonproprietary)
norgestimate and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090523
Marketing start
Listing expires
Identifiers
Product ID 50090-4881_8599c5bf-cb1a-4e7a-ac4f-c874766d0983SPL ID 8599c5bf-cb1a-4e7a-ac4f-c874766d0983SPL set ID 2ec8f18f-297c-405f-b191-a40767366badRxCUI 240128, 748797, 749860, 1365899

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

N450090488100 followed by a unit qualifier and the quantity

Package 50090-4881-00. 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.

Indications (excerpt from the label)

Mono-Linyah is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090523

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

FDA NDC Directory listings under ANDA 090523
ProductStrengthForm · routeLabelerProduct NDC
Mono-Linyahnorgestimate and ethinyl estradiol—KitRedpharm Drug67296-2329
Mono-Linyahnorgestimate and ethinyl estradiol—KitNorthstar Rx LLC16714-360
Nymyonorgestimate and ethinyl estradiol—KitMayne Pharma Inc.51862-645

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