What is NDC 0316-0221?

0316-0221 is the product NDC for Nystatin Cream, Nystatin 100000 [USP'U]/g cream, listed with the FDA by Crown Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

Crown Laboratories, NDC labeler code 0316. 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 Cream?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nystatin Cream NDC 0316-0221 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0316-0221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00316-0221Add 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 NDC	11-digit (billing)	Package	Copy
0316-0221-15	0031602211500316022115	1 TUBE in 1 CARTON (0316-0221-15) / 15 g in 1 TUBEMarketed from Oct 10, 2017
0316-0221-30	0031602213000316022130	1 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBEMarketed from Oct 10, 2017

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 Cream
Generic name (nonproprietary): nystatin cream
Active ingredients: Nystatin — 100000 [USP'U]/g
Dosage form: Cream
Route: Topical
Labeler: Crown LaboratoriesNDC labeler code 0316
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207733
Marketing start: Oct 10, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 0316-0221_48342e66-405b-57be-e063-6394a90a276cSPL ID 48342e66-405b-57be-e063-6394a90a276cSPL set ID 5a2b6fee-1437-0c3a-e053-2991aa0a3443RxCUI 543546UNII BDF1O1C72EUPC 0303160221156
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

N400316022115 followed by a unit qualifier and the quantity

Package 00316-0221-15. 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 Jan 12, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0316-0221

What is NDC 0316-0221?: 0316-0221 is the product NDC for Nystatin Cream, Nystatin 100000 [USP'U]/g cream, listed with the FDA by Crown Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nystatin Cream.
What is the active ingredient?: Nystatin.
Who is the labeler?: Crown Laboratories, NDC labeler code 0316. 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 Cream?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.