nystatin

Generic: nystatin

Labeler: mckesson corporation dba sky packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler mckesson corporation dba sky packaging
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nystatin 100000 [USP'U]/mL

Manufacturer
McKesson Corporation dba SKY Packaging

Identifiers & Regulatory

Product NDC 63739-160
Product ID 63739-160_b9d6c916-6063-49b6-86eb-3f4fa8954404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203621
Marketing Start 2024-01-29
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63739160
Hyphenated Format 63739-160

Supplemental Identifiers

RxCUI
312055
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 (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 (63739-160-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
  • 5 TRAY in 1 CASE (63739-160-56) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-160-70)
  • 5 mL in 1 CUP, UNIT-DOSE (63739-160-70)
source: ndc

Packages (3)

63739-160-10 10 TRAY in 1 CASE (63739-160-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 63739-160-56 5 TRAY in 1 CASE (63739-160-56) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-160-70) 63739-160-70 5 mL in 1 CUP, UNIT-DOSE (63739-160-70)

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": "b9d6c916-6063-49b6-86eb-3f4fa8954404", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["eb34e6dc-9459-41ac-ae10-78650284b2bc"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["McKesson Corporation dba SKY Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (63739-160-10)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "63739-160-10", "marketing_end_date": "20260430", "marketing_start_date": "20240129"}, {"sample": false, "description": "5 TRAY in 1 CASE (63739-160-56)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-160-70)", "package_ndc": "63739-160-56", "marketing_end_date": "20260430", "marketing_start_date": "20240129"}, {"sample": false, "description": "5 mL in 1 CUP, UNIT-DOSE (63739-160-70)", "package_ndc": "63739-160-70", "marketing_end_date": "20260430", "marketing_start_date": "20240129"}], "brand_name": "Nystatin", "product_id": "63739-160_b9d6c916-6063-49b6-86eb-3f4fa8954404", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "63739-160", "generic_name": "NYSTATIN", "labeler_name": "McKesson Corporation dba SKY 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_end_date": "20260430", "marketing_start_date": "20240129"}