prednisolone sodium phosphate

Generic: prednisolone sodium phosphate

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

Drug Facts

Product Profile

Brand Name prednisolone sodium phosphate
Generic Name prednisolone sodium phosphate
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone sodium phosphate 15 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0815
Product ID 17856-0815_35cf03f4-200d-5643-e063-6394a90a9e02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203559
Listing Expiration 2026-12-31
Marketing Start 2023-10-09

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560815
Hyphenated Format 17856-0815

Supplemental Identifiers

RxCUI
283077
UNII
IV021NXA9J

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 prednisolone sodium phosphate (source: ndc)
Generic Name prednisolone sodium phosphate (source: ndc)
Application Number ANDA203559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE
  • 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3) / 5 mL in 1 SYRINGE
source: ndc

Packages (3)

17856-0815-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE 17856-0815-2 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE 17856-0815-3 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3) / 5 mL in 1 SYRINGE

Ingredients (1)

prednisolone sodium phosphate (15 mg/5mL)

Linked Drug Pages (1)

Prednisolone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35cf03f4-200d-5643-e063-6394a90a9e02", "openfda": {"unii": ["IV021NXA9J"], "rxcui": ["283077"], "spl_set_id": ["96de9cad-2fb7-4947-87ae-4db57563a83a"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0815-1", "marketing_start_date": "20250115"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2)  / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0815-2", "marketing_start_date": "20250115"}, {"sample": false, "description": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3)  / 5 mL in 1 SYRINGE", "package_ndc": "17856-0815-3", "marketing_start_date": "20250115"}], "brand_name": "Prednisolone Sodium Phosphate", "product_id": "17856-0815_35cf03f4-200d-5643-e063-6394a90a9e02", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "17856-0815", "generic_name": "Prednisolone Sodium Phosphate", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone Sodium Phosphate", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "15 mg/5mL"}], "application_number": "ANDA203559", "marketing_category": "ANDA", "marketing_start_date": "20231009", "listing_expiration_date": "20261231"}