proctozone-hc

Generic: hydrocortisone 2.5%

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proctozone-hc
Generic Name hydrocortisone 2.5%
Labeler rising pharma holdings, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-324
Product ID 64980-324_d929629c-8c27-4e73-a1ae-4e121ad267de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040879
Listing Expiration 2026-12-31
Marketing Start 2015-08-03

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 64980324
Hyphenated Format 64980-324

Supplemental Identifiers

RxCUI
310891 1440936
UPC
0364980324304
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 proctozone-hc (source: ndc)
Generic Name hydrocortisone 2.5% (source: ndc)
Application Number ANDA040879 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (64980-324-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

64980-324-30 1 TUBE in 1 CARTON (64980-324-30) / 30 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 mg/g)

Linked Drug Pages (1)

PROCTOZONE-HC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d929629c-8c27-4e73-a1ae-4e121ad267de", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0364980324304"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891", "1440936"], "spl_set_id": ["fb5746ff-3ff1-4874-a827-4694133641b9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (64980-324-30)  / 30 g in 1 TUBE", "package_ndc": "64980-324-30", "marketing_start_date": "20150803"}], "brand_name": "PROCTOZONE-HC", "product_id": "64980-324_d929629c-8c27-4e73-a1ae-4e121ad267de", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64980-324", "generic_name": "hydrocortisone 2.5%", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCTOZONE-HC", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA040879", "marketing_category": "ANDA", "marketing_start_date": "20150803", "listing_expiration_date": "20261231"}