NDC codes

FDA NDC Directory
Product NDC (as listed)17856-0508Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-0508Add 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
17856-0508-1178560508011785605080172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Jul 15, 2024
17856-0508-3178560508031785605080348 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGEMarketed from Jul 17, 2024
17856-0508-5178560508051785605080548 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGEMarketed from Jul 17, 2024
17856-0508-71785605080717856050807120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGEMarketed from Jul 17, 2024

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)
Nystatin
Generic name (nonproprietary)
nystatin
Active ingredients
Nystatin — 100000 [USP'U]/mL
Dosage form
Suspension
Route
Oral
Labeler
ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214346
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2SPL ID 484acdef-5f40-bd3e-e063-6394a90aebe2SPL set ID 5c08148f-83e5-4f14-b0d3-af8d2c26062eRxCUI 312055UNII BDF1O1C72E
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N417856050801 followed by a unit qualifier and the quantity

Package 17856-0508-01. 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 oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 17856-0508

What is NDC 17856-0508?
17856-0508 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 4 package NDCs, 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?
ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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?
77 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.68788-856168788-8561-0468788-8561-06
NystatinNystatin 100000 [USP'U]/mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-354368071-3543-06

All 78 Nystatin NDCs

Other NDCs under ANDA 214346

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

FDA NDC Directory listings under ANDA 214346
ProductStrengthForm · routeLabelerProduct NDC
NystatinNystatin 100000 [USP'U]/mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-3543
NystatinNystatin 100000 [USP'U]/mLSuspensionOralPreferred Pharmaceuticals Inc.68788-8561
NystatinNystatin 100000 [USP'U]/mLSuspensionOralLeading Pharma, LLC69315-504

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