nystatin cream

Generic: nystatin cream

Labeler: crown laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin cream
Generic Name nystatin cream
Labeler crown laboratories
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Crown Laboratories

Identifiers & Regulatory

Product NDC 0316-0221
Product ID 0316-0221_48342e66-405b-57be-e063-6394a90a276c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207733
Listing Expiration 2027-12-31
Marketing Start 2017-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03160221
Hyphenated Format 0316-0221

Supplemental Identifiers

RxCUI
543546
UPC
0303160221156
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

Packaging Origin

Original Packager
true

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 cream (source: ndc)
Generic Name nystatin cream (source: ndc)
Application Number ANDA207733 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0316-0221-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

0316-0221-15 1 TUBE in 1 CARTON (0316-0221-15) / 15 g in 1 TUBE 0316-0221-30 1 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBE

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Nystatin Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48342e66-405b-57be-e063-6394a90a276c", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0303160221156"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["5a2b6fee-1437-0c3a-e053-2991aa0a3443"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Crown Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0316-0221-15)  / 15 g in 1 TUBE", "package_ndc": "0316-0221-15", "marketing_start_date": "20171010"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0316-0221-30)  / 30 g in 1 TUBE", "package_ndc": "0316-0221-30", "marketing_start_date": "20171010"}], "brand_name": "Nystatin Cream", "product_id": "0316-0221_48342e66-405b-57be-e063-6394a90a276c", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0316-0221", "generic_name": "Nystatin Cream", "labeler_name": "Crown Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin Cream", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA207733", "marketing_category": "ANDA", "marketing_start_date": "20171010", "listing_expiration_date": "20271231"}