NDC codes

FDA NDC Directory
Product NDC (as listed)0093-0983Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-0983Add 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
0093-0983-010009309830100093098301100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01)Marketed from Sep 30, 1990

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500000 [USP'U]/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062506
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4SPL ID b55205c3-f0be-44eb-a267-3af07c1639f4SPL set ID f03b294d-10cd-4bba-92c8-42ae9b110cd0RxCUI 312059UNII 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

N400093098301 followed by a unit qualifier and the quantity

Package 00093-0983-01. 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 tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-0983

What is NDC 0093-0983?
0093-0983 is the product NDC for Nystatin, Nystatin 500000 [USP'U]/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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]/mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-050817856-0508-0117856-0508-0317856-0508-05+1 more

All 78 Nystatin NDCs

Other NDCs under ANDA 062506

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

FDA NDC Directory listings under ANDA 062506
ProductStrengthForm · routeLabelerProduct NDC
NystatinNystatin 500000 [USP'U]/1Tablet, Film coatedOralAvKARE42291-651

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