hydrocortisone

Generic: hydrocortisone

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 10 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1697
Product ID 0115-1697_f28149c1-c377-40ad-9d87-2f909eacf9e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040646
Listing Expiration 2026-12-31
Marketing Start 2007-03-30

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 01151697
Hyphenated Format 0115-1697

Supplemental Identifiers

RxCUI
197782 197783 197787
UPC
0301151696068 0301151700017 0301151697010
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 ANDA040646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01)
source: ndc

Packages (1)

0115-1697-01 100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01)

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": "f28149c1-c377-40ad-9d87-2f909eacf9e9", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301151696068", "0301151700017", "0301151697010"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["9fe627ad-4aba-4bd1-8590-6cc2d61674ba"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01)", "package_ndc": "0115-1697-01", "marketing_start_date": "20070330"}], "brand_name": "HYDROCORTISONE", "product_id": "0115-1697_f28149c1-c377-40ad-9d87-2f909eacf9e9", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0115-1697", "generic_name": "hydrocortisone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20070330", "listing_expiration_date": "20261231"}