NDC codes

FDA NDC Directory
Product NDC (as listed)63187-847Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0847Add 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
63187-847-15631870847151 TUBE in 1 CARTON (63187-847-15) / 15 g in 1 TUBEMarketed from May 1, 2017
63187-847-30631870847301 TUBE in 1 CARTON (63187-847-30) / 30 g in 1 TUBEMarketed from May 1, 2017

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)
Nystatin
Generic name (nonproprietary)
nystatin
Active ingredients
Nystatin — 100000 [USP'U]/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062225
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 63187-847_d13c0ace-65a3-4d56-bfce-c4aa234af26bSPL ID d13c0ace-65a3-4d56-bfce-c4aa234af26bSPL set ID e7f0e152-233a-492e-a297-7bf2c543c113RxCUI 543546UNII BDF1O1C72EUPC 0363187847302
Pharmacologic class
Polyene Antifungal

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463187084715 followed by a unit qualifier and the quantity

Package 63187-0847-15. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 062225

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

FDA NDC Directory listings under ANDA 062225
ProductStrengthForm · routeLabelerProduct NDC
MycostatinnystatinNystatin 100000 [USP'U]/gCreamTopicalDirect_Rx72189-408
NystatinNystatin 100000 [USP'U]/gCreamTopicalNuCare Pharmaceuticals,Inc.66267-953
NystatinNystatin 100000 [USP'U]/gCreamTopicalBryant Ranch Prepack72162-1385
NystatinNystatin 100000 [USP'U]/gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-059
NystatinNystatin 100000 [USP'U]/gCreamTopicalBryant Ranch Prepack63629-8695
NystatinNystatin 100000 [USP'U]/gCreamTopicalBryant Ranch Prepack63629-8694
NystatinNystatin 100000 [USP'U]/gCreamTopicalA-S Medication Solutions50090-2763
NystatinNystatin 100000 [USP'U]/gCreamTopicalBryant Ranch Prepack71335-2830
NystatinNystatin 100000 [USP'U]/gCreamTopicalNuCare Pharmaceuticals,Inc.68071-4293
NystatinNystatin 100000 [USP'U]/gCreamTopicalA-S Medication Solutions50090-2854

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