nystatin

Generic: nystatin

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler american health packaging
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-800
Product ID 60687-800_11ff6ced-6e23-9aa1-e063-6294a90a7c04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203621
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687800
Hyphenated Format 60687-800

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 ANDA203621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (60687-800-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40)
source: ndc

Packages (1)

60687-800-17 10 TRAY in 1 CASE (60687-800-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40)

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": "11ff6ced-6e23-9aa1-e063-6294a90a7c04", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["d8c251a6-d4da-4664-bff4-6868541d1178"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (60687-800-17)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46)  / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40)", "package_ndc": "60687-800-17", "marketing_start_date": "20240226"}], "brand_name": "Nystatin", "product_id": "60687-800_11ff6ced-6e23-9aa1-e063-6294a90a7c04", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "60687-800", "generic_name": "Nystatin", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/mL"}], "application_number": "ANDA203621", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}