deflazacort oral suspension

Generic: deflazacort oral

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deflazacort oral suspension
Generic Name deflazacort oral
Labeler sun pharmaceutical industries, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

deflazacort 22.75 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-993
Product ID 57664-993_4962347e-353c-558e-e063-6394a90a6861
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219930
Listing Expiration 2027-12-31
Marketing Start 2026-02-02

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664993
Hyphenated Format 57664-993

Supplemental Identifiers

RxCUI
1870964
UPC
0357664993019
UNII
KR5YZ6AE4B
NUI
N0000175576 N0000175450

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 deflazacort oral suspension (source: ndc)
Generic Name deflazacort oral (source: ndc)
Application Number ANDA219930 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 22.75 mg/mL
source: ndc
Packaging
  • 13 mL in 1 BOTTLE (57664-993-01)
source: ndc

Packages (1)

57664-993-01 13 mL in 1 BOTTLE (57664-993-01)

Ingredients (1)

deflazacort (22.75 mg/mL)

Linked Drug Pages (1)

Deflazacort Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4962347e-353c-558e-e063-6394a90a6861", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0357664993019"], "unii": ["KR5YZ6AE4B"], "rxcui": ["1870964"], "spl_set_id": ["2fac1332-0247-1047-e063-6294a90a557f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "13 mL in 1 BOTTLE (57664-993-01)", "package_ndc": "57664-993-01", "marketing_start_date": "20260202"}], "brand_name": "Deflazacort Oral Suspension", "product_id": "57664-993_4962347e-353c-558e-e063-6394a90a6861", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "57664-993", "generic_name": "Deflazacort Oral", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deflazacort Oral Suspension", "active_ingredients": [{"name": "DEFLAZACORT", "strength": "22.75 mg/mL"}], "application_number": "ANDA219930", "marketing_category": "ANDA", "marketing_start_date": "20260202", "listing_expiration_date": "20271231"}