hydrocortisone

Generic: hydrocortisone

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0146
Product ID 0168-0146_d4641721-bb32-4cf7-b17f-78886ffbce17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081203
Listing Expiration 2027-12-31
Marketing Start 1993-05-28

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 01680146
Hyphenated Format 0168-0146

Supplemental Identifiers

RxCUI
103401 310891
UPC
0301680146300 0301680080314
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 ANDA081203 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 454 g in 1 JAR (0168-0146-16)
  • 29 g in 1 TUBE (0168-0146-30)
source: ndc

Packages (2)

0168-0146-16 454 g in 1 JAR (0168-0146-16) 0168-0146-30 29 g in 1 TUBE (0168-0146-30)

Ingredients (1)

hydrocortisone (25 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": "d4641721-bb32-4cf7-b17f-78886ffbce17", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301680146300", "0301680080314"], "unii": ["WI4X0X7BPJ"], "rxcui": ["103401", "310891"], "spl_set_id": ["bcd103f3-3dc8-4394-b8fd-8f8ddb721f77"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "454 g in 1 JAR (0168-0146-16)", "package_ndc": "0168-0146-16", "marketing_start_date": "19930528"}, {"sample": false, "description": "29 g in 1 TUBE (0168-0146-30)", "package_ndc": "0168-0146-30", "marketing_start_date": "19930528"}], "brand_name": "Hydrocortisone", "product_id": "0168-0146_d4641721-bb32-4cf7-b17f-78886ffbce17", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0146", "generic_name": "Hydrocortisone", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA081203", "marketing_category": "ANDA", "marketing_start_date": "19930528", "listing_expiration_date": "20271231"}