hydrocortisone

Generic: hydrocortisone

Labeler: crown laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler crown laboratories
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Crown Laboratories

Identifiers & Regulatory

Product NDC 0316-0186
Product ID 0316-0186_48343bf7-453f-6b2e-e063-6394a90a05f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080706
Listing Expiration 2027-12-31
Marketing Start 1973-03-09

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 03160186
Hyphenated Format 0316-0186

Supplemental Identifiers

RxCUI
106258 310891
UPC
0303160193309 0303160186011
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 ANDA080706 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0316-0186-01) / 28.4 g in 1 TUBE
  • 1 JAR in 1 CARTON (0316-0186-16) / 454 g in 1 JAR
source: ndc

Packages (2)

0316-0186-01 1 TUBE in 1 CARTON (0316-0186-01) / 28.4 g in 1 TUBE 0316-0186-16 1 JAR in 1 CARTON (0316-0186-16) / 454 g in 1 JAR

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": "48343bf7-453f-6b2e-e063-6394a90a05f6", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0303160193309", "0303160186011"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258", "310891"], "spl_set_id": ["a84830ad-73dc-4a2e-b987-0a1103526535"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Crown Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0316-0186-01)  / 28.4 g in 1 TUBE", "package_ndc": "0316-0186-01", "marketing_start_date": "19730309"}, {"sample": false, "description": "1 JAR in 1 CARTON (0316-0186-16)  / 454 g in 1 JAR", "package_ndc": "0316-0186-16", "marketing_start_date": "20170102"}], "brand_name": "Hydrocortisone", "product_id": "0316-0186_48343bf7-453f-6b2e-e063-6394a90a05f6", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0316-0186", "generic_name": "Hydrocortisone", "labeler_name": "Crown Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "ANDA080706", "marketing_category": "ANDA", "marketing_start_date": "19730309", "listing_expiration_date": "20271231"}