nystatin

Generic: nystatin cream

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin cream
Labeler nucare pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3911
Product ID 68071-3911_42f2113b-4399-d2bb-e063-6394a90a7cb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061966
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

Pharmacologic Class

Established (EPC)
polyene antifungal [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713911
Hyphenated Format 68071-3911

Supplemental Identifiers

RxCUI
543546
UPC
0368071391152
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nystatin (source: ndc)
Generic Name nystatin cream (source: ndc)
Application Number ANDA061966 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68071-3911-5) / 15 g in 1 TUBE
source: ndc

Packages (1)

68071-3911-5 1 TUBE in 1 CARTON (68071-3911-5) / 15 g in 1 TUBE

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42f2113b-4399-d2bb-e063-6394a90a7cb7", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0368071391152"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["42f21220-c68a-d748-e063-6394a90a1e2f"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68071-3911-5)  / 15 g in 1 TUBE", "package_ndc": "68071-3911-5", "marketing_start_date": "20251106"}], "brand_name": "Nystatin", "product_id": "68071-3911_42f2113b-4399-d2bb-e063-6394a90a7cb7", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68071-3911", "generic_name": "Nystatin Cream", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA061966", "marketing_category": "ANDA", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}