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 10 mg/g

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

Identifiers & Regulatory

Product NDC 0168-0020
Product ID 0168-0020_bfa9683a-fde4-462c-81b3-2ed398307a99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080692
Listing Expiration 2027-12-31
Marketing Start 1975-04-16

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 01680020
Hyphenated Format 0168-0020

Supplemental Identifiers

RxCUI
203105
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 ANDA080692 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 453.6 g in 1 JAR (0168-0020-16)
  • 1 TUBE in 1 CARTON (0168-0020-31) / 28.35 g in 1 TUBE
source: ndc

Packages (2)

0168-0020-16 453.6 g in 1 JAR (0168-0020-16) 0168-0020-31 1 TUBE in 1 CARTON (0168-0020-31) / 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": "bfa9683a-fde4-462c-81b3-2ed398307a99", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["203105"], "spl_set_id": ["31fbb576-0e76-471c-83c8-9e0125bc1791"], "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": "453.6 g in 1 JAR (0168-0020-16)", "package_ndc": "0168-0020-16", "marketing_start_date": "19750416"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0020-31)  / 28.35 g in 1 TUBE", "package_ndc": "0168-0020-31", "marketing_start_date": "19750416"}], "brand_name": "Hydrocortisone", "product_id": "0168-0020_bfa9683a-fde4-462c-81b3-2ed398307a99", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0020", "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": "10 mg/g"}], "application_number": "ANDA080692", "marketing_category": "ANDA", "marketing_start_date": "19750416", "listing_expiration_date": "20271231"}