deflazacort oral suspension

Generic: deflazacort

Labeler: doppel farmaceutici s.r.l.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deflazacort oral suspension
Generic Name deflazacort
Labeler doppel farmaceutici s.r.l.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

deflazacort 22.75 mg/mL

Manufacturer
Doppel Farmaceutici S.r.l.

Identifiers & Regulatory

Product NDC 81806-200
Product ID 81806-200_40a833b9-1c02-ffe2-e063-6294a90aac4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA220042
Listing Expiration 2026-12-31
Marketing Start 2025-10-23

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 81806200
Hyphenated Format 81806-200

Supplemental Identifiers

RxCUI
1870964
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 (source: ndc)
Application Number ANDA220042 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 22.75 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (81806-200-73) / 13 mL in 1 BOTTLE
source: ndc

Packages (1)

81806-200-73 1 BOTTLE in 1 CARTON (81806-200-73) / 13 mL in 1 BOTTLE

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": "40a833b9-1c02-ffe2-e063-6294a90aac4e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["KR5YZ6AE4B"], "rxcui": ["1870964"], "spl_set_id": ["40a833a4-e029-a99e-e063-6394a90afd50"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Doppel Farmaceutici S.r.l."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (81806-200-73)  / 13 mL in 1 BOTTLE", "package_ndc": "81806-200-73", "marketing_start_date": "20251023"}], "brand_name": "Deflazacort Oral Suspension", "product_id": "81806-200_40a833b9-1c02-ffe2-e063-6294a90aac4e", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "81806-200", "generic_name": "Deflazacort", "labeler_name": "Doppel Farmaceutici S.r.l.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deflazacort Oral Suspension", "active_ingredients": [{"name": "DEFLAZACORT", "strength": "22.75 mg/mL"}], "application_number": "ANDA220042", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}