NDC codes

FDA NDC Directory
Product NDC (as listed)41250-982Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0982Add 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
41250-982-00412500982001 KIT in 1 CARTON (41250-982-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBEMarketed from Oct 12, 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)
Miconazole 3
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076357
Marketing start
Listing expires
Identifiers
Product ID 41250-982_5851615b-ccaa-4173-9aba-ad8c64a6c612SPL ID 5851615b-ccaa-4173-9aba-ad8c64a6c612SPL set ID c915a495-8eac-4a1a-83a4-c874682433c8RxCUI 992816, 998483, 998540, 998544

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

N441250098200 followed by a unit qualifier and the quantity

Package 41250-0982-00. 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 .

Indications (excerpt from the label)

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076357

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

FDA NDC Directory listings under ANDA 076357
ProductStrengthForm · routeLabelerProduct NDC
foster and thrive miconazole 3miconazole nitrate—KitStrategic Sourcing Services LLC70677-1223
Rugby Miconazole 3miconazole nitrate—KitRugby Laboratories0536-1425
Up and Up Miconazole 3miconazole nitrate—KitTarget Corporation11673-982
Leader Miconazole 3miconazole nitrate—KitCardinal Health 110, LLC. dba Leader70000-0669
Miconazole 3miconazole nitrate—KitRite Aid Corporation11822-0800
Miconazole 3miconazole nitrate—KitCVS Pharmacy59779-839

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