nystatin

Generic: nystatin

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0538
Product ID 17856-0538_3b3e4301-f8a2-d53f-e063-6394a90a111b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062512
Listing Expiration 2026-12-31
Marketing Start 1995-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560538
Hyphenated Format 17856-0538

Supplemental Identifiers

RxCUI
312055
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 (source: ndc)
Application Number ANDA062512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension. 60 mL bottles with a calibrated dropper and 1 Pint (473 mL) bottles. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL) Fruit Flavored Rx Only image description image description
source: label

Packages (0)

No package records.

Ingredients (1)

nystatin (100000 [USP'U]/mL)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b3e4301-f8a2-d53f-e063-6394a90a111b", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["8d3531b9-13b4-471b-8315-9d05c80208f6"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [], "brand_name": "Nystatin", "product_id": "17856-0538_3b3e4301-f8a2-d53f-e063-6394a90a111b", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "17856-0538", "generic_name": "Nystatin", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA062512", "marketing_category": "ANDA", "marketing_start_date": "19950415", "listing_expiration_date": "20261231"}