procto-med hc

Generic: hydrocortisone

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name procto-med hc
Generic Name hydrocortisone
Labeler leading pharma, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-312
Product ID 69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085025
Listing Expiration 2027-12-31
Marketing Start 2020-02-14

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 69315312
Hyphenated Format 69315-312

Supplemental Identifiers

RxCUI
310891 1790684
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 procto-med hc (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number ANDA085025 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69315-312-28) / 28 g in 1 TUBE
source: ndc

Packages (1)

69315-312-28 1 TUBE in 1 CARTON (69315-312-28) / 28 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

Procto-Med HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "614fdcc8-43c2-4c42-a7fe-016844f338d8", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891", "1790684"], "spl_set_id": ["0682580e-aff8-4b67-99ba-a29ab7b433db"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69315-312-28)  / 28 g in 1 TUBE", "package_ndc": "69315-312-28", "marketing_start_date": "20200214"}], "brand_name": "Procto-Med HC", "product_id": "69315-312_614fdcc8-43c2-4c42-a7fe-016844f338d8", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69315-312", "generic_name": "HYDROCORTISONE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Procto-Med HC", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA085025", "marketing_category": "ANDA", "marketing_start_date": "20200214", "listing_expiration_date": "20271231"}