hydrocortisone

Generic: hydrocortisone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-413
Product ID 59651-413_29a517ee-f3ee-43d8-9fd7-27bd39d07600
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214649
Listing Expiration 2026-12-31
Marketing Start 2023-07-17

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 59651413
Hyphenated Format 59651-413

Supplemental Identifiers

RxCUI
197782 197783 197787
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 (source: ndc)
Application Number ANDA214649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (59651-413-50)
source: ndc

Packages (1)

59651-413-50 50 TABLET in 1 BOTTLE (59651-413-50)

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": "29a517ee-f3ee-43d8-9fd7-27bd39d07600", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["6d820911-f50e-46a4-8174-c4ee89f6792e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (59651-413-50)", "package_ndc": "59651-413-50", "marketing_start_date": "20230717"}], "brand_name": "HYDROCORTISONE", "product_id": "59651-413_29a517ee-f3ee-43d8-9fd7-27bd39d07600", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59651-413", "generic_name": "HYDROCORTISONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "ANDA214649", "marketing_category": "ANDA", "marketing_start_date": "20230717", "listing_expiration_date": "20261231"}