hydrocortisone

Generic: drs. hydrocortisone

Labeler: ol pharma tech,llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name drs. hydrocortisone
Labeler ol pharma tech,llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
OL PHARMA TECH,LLC

Identifiers & Regulatory

Product NDC 80489-001
Product ID 80489-001_48fe7e3f-613b-4f28-e063-6294a90aa4e0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2021-01-01

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 80489001
Hyphenated Format 80489-001

Supplemental Identifiers

RxCUI
106258
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 drs. hydrocortisone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80489-001-01) / 28.3 g in 1 TUBE
  • 1 TUBE in 1 CARTON (80489-001-02) / 49.5 g in 1 TUBE
source: ndc

Packages (2)

80489-001-01 1 TUBE in 1 CARTON (80489-001-01) / 28.3 g in 1 TUBE 80489-001-02 1 TUBE in 1 CARTON (80489-001-02) / 49.5 g in 1 TUBE

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48fe7e3f-613b-4f28-e063-6294a90aa4e0", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["b0eac8f3-bb80-6563-e053-2995a90a83c9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["OL PHARMA TECH,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80489-001-01)  / 28.3 g in 1 TUBE", "package_ndc": "80489-001-01", "marketing_start_date": "20210101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (80489-001-02)  / 49.5 g in 1 TUBE", "package_ndc": "80489-001-02", "marketing_start_date": "20210101"}], "brand_name": "Hydrocortisone", "product_id": "80489-001_48fe7e3f-613b-4f28-e063-6294a90aa4e0", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80489-001", "generic_name": "Drs. Hydrocortisone", "labeler_name": "OL PHARMA TECH,LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210101", "listing_expiration_date": "20271231"}