hydrocortisone

Generic: hydrocortisone

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
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 inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0015
Product ID 0168-0015_b0fa74e7-15d7-47e6-9cb8-9471fc75d796
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080693
Listing Expiration 2026-12-31
Marketing Start 1976-04-30

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 01680015
Hyphenated Format 0168-0015

Supplemental Identifiers

RxCUI
106258
UPC
0301680015316
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 ANDA080693 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 453.6 g in 1 JAR (0168-0015-16)
  • 1 TUBE in 1 CARTON (0168-0015-31) / 28.35 g in 1 TUBE
source: ndc

Packages (2)

0168-0015-16 453.6 g in 1 JAR (0168-0015-16) 0168-0015-31 1 TUBE in 1 CARTON (0168-0015-31) / 28.35 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": "b0fa74e7-15d7-47e6-9cb8-9471fc75d796", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301680015316"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["bc374fa4-ac8b-408e-9321-8bab97a18770"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "453.6 g in 1 JAR (0168-0015-16)", "package_ndc": "0168-0015-16", "marketing_start_date": "19760430"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0015-31)  / 28.35 g in 1 TUBE", "package_ndc": "0168-0015-31", "marketing_start_date": "19760430"}], "brand_name": "hydrocortisone", "product_id": "0168-0015_b0fa74e7-15d7-47e6-9cb8-9471fc75d796", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0015", "generic_name": "Hydrocortisone", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "ANDA080693", "marketing_category": "ANDA", "marketing_start_date": "19760430", "listing_expiration_date": "20261231"}