hydrocortisone

Generic: hydrocortisone

Labeler: trifluent pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler trifluent pharma llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/mL

Manufacturer
Trifluent Pharma LLC

Identifiers & Regulatory

Product NDC 73352-455
Product ID 73352-455_1c65bd29-4b72-4efc-8b4e-86b492a4b190
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081271
Listing Expiration 2026-12-31
Marketing Start 2024-11-22

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 73352455
Hyphenated Format 73352-455

Supplemental Identifiers

RxCUI
197786
UPC
0373352455010
UNII
WI4X0X7BPJ
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 hydrocortisone (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA081271 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (73352-455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

73352-455-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON (73352-455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

hydrocortisone (25 mg/mL)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1c65bd29-4b72-4efc-8b4e-86b492a4b190", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0373352455010"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197786"], "spl_set_id": ["20508a94-01bc-4f1d-a42b-122a31402aaf"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Trifluent Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (73352-455-01)  / 30 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "73352-455-01", "marketing_start_date": "20241122"}], "brand_name": "Hydrocortisone", "product_id": "73352-455_1c65bd29-4b72-4efc-8b4e-86b492a4b190", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "73352-455", "generic_name": "Hydrocortisone", "labeler_name": "Trifluent Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/mL"}], "application_number": "ANDA081271", "marketing_category": "ANDA", "marketing_start_date": "20241122", "listing_expiration_date": "20261231"}