hydrocortisone

Generic: hydrocortisone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler remedyrepack inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 25 mg/g

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3078
Product ID 70518-3078_44852fa2-9a51-368d-e063-6294a90a4dcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085025
Listing Expiration 2026-12-31
Marketing Start 2021-04-22

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 705183078
Hyphenated Format 70518-3078

Supplemental Identifiers

RxCUI
310891
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 ANDA085025 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (70518-3078-0) / 20 g in 1 TUBE
source: ndc

Packages (1)

70518-3078-0 1 TUBE in 1 CARTON (70518-3078-0) / 20 g in 1 TUBE

Ingredients (1)

hydrocortisone (25 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": "44852fa2-9a51-368d-e063-6294a90a4dcf", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310891"], "spl_set_id": ["f0e66726-946b-4f63-b457-2851dc69e6b4"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70518-3078-0)  / 20 g in 1 TUBE", "package_ndc": "70518-3078-0", "marketing_start_date": "20210422"}], "brand_name": "Hydrocortisone", "product_id": "70518-3078_44852fa2-9a51-368d-e063-6294a90a4dcf", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70518-3078", "generic_name": "Hydrocortisone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "25 mg/g"}], "application_number": "ANDA085025", "marketing_category": "ANDA", "marketing_start_date": "20210422", "listing_expiration_date": "20261231"}