What is NDC 63629-8350?

63629-8350 is the product NDC for nystatin, Nystatin 500000 [USP'U]/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

nystatin NDC 63629-8350 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8350Add 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
63629-8350-1	6362983500163629835001	28 TABLET, COATED in 1 BOTTLE (63629-8350-1)Marketed from Apr 29, 2022
63629-8350-2	6362983500263629835002	56 TABLET, COATED in 1 BOTTLE (63629-8350-2)Marketed from Sep 2, 2020
63629-8350-3	6362983500363629835003	30 TABLET, COATED in 1 BOTTLE (63629-8350-3)Marketed from Sep 2, 2020
63629-8350-4	6362983500463629835004	120 TABLET, COATED in 1 BOTTLE (63629-8350-4)Marketed from Jun 7, 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 — 500000 [USP'U]/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062474
Marketing start: Oct 31, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 63629-8350_3ac0334d-5698-4b3a-8ac8-7594526ec50cSPL ID 3ac0334d-5698-4b3a-8ac8-7594526ec50cSPL set ID a5711dbe-f71c-435c-91f2-38c357532d18RxCUI 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

N463629835001 followed by a unit qualifier and the quantity

Package 63629-8350-01. 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 Aug 19, 2025.

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 63629-8350

What is NDC 63629-8350?: 63629-8350 is the product NDC for nystatin, Nystatin 500000 [USP'U]/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-4099	68788-4099-01
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Genus Lifesciences Inc.	64950-372	64950-0372-0664950-0372-47
Nystatin	Nystatin 100000 [USP'U]/g	PowderTopical	Northstar Rx LLC	72603-491	72603-0491-0172603-0491-0272603-0491-03
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Aurobindo Pharma Limited	59651-907	59651-0907-1459651-0907-30
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8690	68788-8690-01
Nystatin	Nystatin 100000 [USP'U]/g	PowderTopical	Dr. Reddy's Labratories Inc.	75907-060	75907-0060-3075907-0060-4475907-0060-60
Nystatin	Nystatin 100000 U/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8631	68788-8631-0168788-8631-03
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	American Health Packaging	60687-800	60687-0800-17
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8561	68788-8561-0468788-8561-06
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-0508	17856-0508-0117856-0508-0317856-0508-05+1 more

All 78 nystatin NDCs

Other NDCs under ANDA 062474

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

FDA NDC Directory listings under ANDA 062474
Product	Strength	Form · route	Labeler	Product NDC
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-051
Nystatin	Nystatin 500000 [USP'U]/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-741
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	NuCare Pharmaceuticals,Inc.	68071-3508
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8690
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Proficient Rx LP	71205-575