orapred odt

Generic: prednisolone sodium phosphate

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orapred odt
Generic Name prednisolone sodium phosphate
Labeler advanz pharma (us) corp.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

prednisolone sodium phosphate 30 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-702
Product ID 59212-702_d172c0d5-b118-4433-92bd-05214976dd8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021959
Listing Expiration 2026-12-31
Marketing Start 2006-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59212702
Hyphenated Format 59212-702

Supplemental Identifiers

RxCUI
643123 643125 643127 647127 668658 668660
UNII
IV021NXA9J

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 orapred odt (source: ndc)
Generic Name prednisolone sodium phosphate (source: ndc)
Application Number NDA021959 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (59212-702-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-702-06)
source: ndc

Packages (1)

59212-702-12 2 BLISTER PACK in 1 CARTON (59212-702-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-702-06)

Ingredients (1)

prednisolone sodium phosphate (30 mg/1)

Linked Drug Pages (1)

Orapred ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d172c0d5-b118-4433-92bd-05214976dd8f", "openfda": {"unii": ["IV021NXA9J"], "rxcui": ["643123", "643125", "643127", "647127", "668658", "668660"], "spl_set_id": ["1e379543-c4cf-4e72-953b-db15b7f0c2a1"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (59212-702-12)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-702-06)", "package_ndc": "59212-702-12", "marketing_start_date": "20200630"}], "brand_name": "Orapred ODT", "product_id": "59212-702_d172c0d5-b118-4433-92bd-05214976dd8f", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59212-702", "generic_name": "prednisolone sodium phosphate", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orapred", "brand_name_suffix": "ODT", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "30 mg/1"}], "application_number": "NDA021959", "marketing_category": "NDA", "marketing_start_date": "20060601", "listing_expiration_date": "20261231"}