hydrocortisone

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8455
Product ID 68788-8455_602f9ec4-0b7b-4ae4-b8b7-2bbd4fe62cfd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040646
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

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 687888455
Hyphenated Format 68788-8455

Supplemental Identifiers

RxCUI
197787
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 ANDA040646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (68788-8455-3)
  • 60 TABLET in 1 BOTTLE, PLASTIC (68788-8455-6)
  • 90 TABLET in 1 BOTTLE, PLASTIC (68788-8455-9)
source: ndc

Packages (3)

68788-8455-3 30 TABLET in 1 BOTTLE, PLASTIC (68788-8455-3) 68788-8455-6 60 TABLET in 1 BOTTLE, PLASTIC (68788-8455-6) 68788-8455-9 90 TABLET in 1 BOTTLE, PLASTIC (68788-8455-9)

Ingredients (1)

hydrocortisone (5 mg/1)

Linked Drug Pages (1)

HYDROCORTISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "602f9ec4-0b7b-4ae4-b8b7-2bbd4fe62cfd", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197787"], "spl_set_id": ["0bbb8a63-ae1d-41d7-b201-d1b171b31f46"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (68788-8455-3)", "package_ndc": "68788-8455-3", "marketing_start_date": "20230605"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (68788-8455-6)", "package_ndc": "68788-8455-6", "marketing_start_date": "20230605"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (68788-8455-9)", "package_ndc": "68788-8455-9", "marketing_start_date": "20230605"}], "brand_name": "HYDROCORTISONE", "product_id": "68788-8455_602f9ec4-0b7b-4ae4-b8b7-2bbd4fe62cfd", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68788-8455", "generic_name": "hydrocortisone", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}