NDC codes

FDA NDC Directory
Product NDC (as listed)63187-464Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0464Add 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
63187-464-15631870464151 TUBE in 1 CARTON (63187-464-15) / 15 g in 1 TUBEMarketed from Jan 1, 2019

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
Ointment
Route
Topical
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062840
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 63187-464_2aeb648a-b45f-4dd7-93f0-610d7490b464SPL ID 2aeb648a-b45f-4dd7-93f0-610d7490b464SPL set ID d7d04c02-d07d-4382-8f93-5c0c3e68790cRxCUI 884308UNII BDF1O1C72EUPC 0363187464158
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

N463187046415 followed by a unit qualifier and the quantity

Package 63187-0464-15. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-464

What is NDC 63187-464?
63187-464 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/g ointment, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nystatin.
What is the active ingredient?
Nystatin.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nystatin?
78 other product NDCs are listed under this name. See all Nystatin 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 Nystatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NystatinNystatin 100000 [USP'U]/gCreamTopicalPreferred Pharmaceuticals Inc.68788-409968788-4099-01
NystatinNystatin 100000 [USP'U]/mLSuspensionOralGenus Lifesciences Inc.64950-37264950-0372-0664950-0372-47
NystatinNystatin 100000 [USP'U]/gPowderTopicalNorthstar Rx LLC72603-49172603-0491-0172603-0491-0272603-0491-03
NystatinNystatin 100000 [USP'U]/gCreamTopicalAurobindo Pharma Limited59651-90759651-0907-1459651-0907-30
nystatinNystatin 500000 [USP'U]/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-869068788-8690-01
NystatinNystatin 100000 [USP'U]/gPowderTopicalDr. Reddy's Labratories Inc.75907-06075907-0060-3075907-0060-4475907-0060-60
NystatinNystatin 100000 U/gCreamTopicalPreferred Pharmaceuticals Inc.68788-863168788-8631-0168788-8631-03
NystatinNystatin 100000 [USP'U]/mLSuspensionOralAmerican Health Packaging60687-80060687-0800-17
NystatinNystatin 100000 [USP'U]/mLSuspensionOralPreferred Pharmaceuticals Inc.68788-856168788-8561-04
NystatinNystatin 100000 [USP'U]/mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-050817856-0508-0117856-0508-0317856-0508-05+1 more

All 79 Nystatin NDCs

Other NDCs under ANDA 062840

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

FDA NDC Directory listings under ANDA 062840
ProductStrengthForm · routeLabelerProduct NDC
NystatinNystatin 100000 [USP'U]/gOintmentTopicalActavis Pharma, Inc.0472-0166

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