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 17856-0508
Product ID 17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214346
Listing Expiration 2027-12-31
Marketing Start 2022-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560508
Hyphenated Format 17856-0508

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 ANDA214346 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1) / 5 mL in 1 CUP, UNIT-DOSE
  • 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGE
  • 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGE
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGE
source: ndc

Packages (4)

17856-0508-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1) / 5 mL in 1 CUP, UNIT-DOSE 17856-0508-3 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGE 17856-0508-5 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGE 17856-0508-7 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGE

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": "484acdef-5f40-bd3e-e063-6394a90aebe2", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["312055"], "spl_set_id": ["5c08148f-83e5-4f14-b0d3-af8d2c26062e"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0508-1", "marketing_start_date": "20240715"}, {"sample": false, "description": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3)  / 5 mL in 1 SYRINGE", "package_ndc": "17856-0508-3", "marketing_start_date": "20240717"}, {"sample": false, "description": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5)  / 5 mL in 1 SYRINGE", "package_ndc": "17856-0508-5", "marketing_start_date": "20240717"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7)  / 1 mL in 1 SYRINGE", "package_ndc": "17856-0508-7", "marketing_start_date": "20240717"}], "brand_name": "NYSTATIN", "product_id": "17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2", "dosage_form": "SUSPENSION", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "17856-0508", "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": "ANDA214346", "marketing_category": "ANDA", "marketing_start_date": "20221205", "listing_expiration_date": "20271231"}