hydrocortisone

Generic: hydrocortisone lotion

Labeler: allegis holdings llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone lotion
Labeler allegis holdings llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

hydrocortisone 20 mg/mL

Manufacturer
Allegis Holdings LLC

Identifiers & Regulatory

Product NDC 71297-010
Product ID 71297-010_47e771ab-b850-724f-e063-6394a90ac63c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083231
Listing Expiration 2027-12-31
Marketing Start 2024-06-10

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 71297010
Hyphenated Format 71297-010

Supplemental Identifiers

RxCUI
197784
UPC
0371297010028 0371297010011
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 lotion (source: ndc)
Application Number ANDA083231 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATOR
  • 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (2)

71297-010-01 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATOR 71297-010-02 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

hydrocortisone (20 mg/mL)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47e771ab-b850-724f-e063-6394a90ac63c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0371297010028", "0371297010011"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197784"], "spl_set_id": ["1a27d8fa-4025-ed68-e063-6394a90a4f37"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Allegis Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01)  / 29.6 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "71297-010-01", "marketing_start_date": "20240610"}, {"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02)  / 59.2 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "71297-010-02", "marketing_start_date": "20240610"}], "brand_name": "Hydrocortisone", "product_id": "71297-010_47e771ab-b850-724f-e063-6394a90ac63c", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71297-010", "generic_name": "Hydrocortisone Lotion", "labeler_name": "Allegis Holdings LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "20 mg/mL"}], "application_number": "ANDA083231", "marketing_category": "ANDA", "marketing_start_date": "20240610", "listing_expiration_date": "20271231"}