hydrocortisone

Generic: hydrocortisone

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

Drug Facts

Product Profile

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

hydrocortisone 10 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-053
Product ID 70954-053_0d7e8e04-9149-4436-bad1-b700e253b7ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217881
Listing Expiration 2026-12-31
Marketing Start 2025-05-05

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 70954053
Hyphenated Format 70954-053

Supplemental Identifiers

RxCUI
197782 197783 197787
UPC
0370954054108 0370954052104 0370954053101
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 ANDA217881 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-053-10)
source: ndc

Packages (1)

70954-053-10 100 TABLET in 1 BOTTLE (70954-053-10)

Ingredients (1)

hydrocortisone (10 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": "0d7e8e04-9149-4436-bad1-b700e253b7ab", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0370954054108", "0370954052104", "0370954053101"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["0d7e8e04-9149-4436-bad1-b700e253b7ab"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-053-10)", "package_ndc": "70954-053-10", "marketing_start_date": "20250505"}], "brand_name": "Hydrocortisone", "product_id": "70954-053_0d7e8e04-9149-4436-bad1-b700e253b7ab", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70954-053", "generic_name": "Hydrocortisone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/1"}], "application_number": "ANDA217881", "marketing_category": "ANDA", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}