hydrocortisone

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler strides pharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 5 mg/1

Manufacturer
Strides Pharma Inc.

Identifiers & Regulatory

Product NDC 42543-970
Product ID 42543-970_4fea0f23-dfda-444b-8206-ea7e5a078338
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207029
Listing Expiration 2027-12-31
Marketing Start 2021-12-22

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 42543970
Hyphenated Format 42543-970

Supplemental Identifiers

RxCUI
197782 197783 197787
UPC
0342543971066 0342543970250 0342543972063
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 ANDA207029 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25)
source: ndc

Packages (1)

42543-970-25 50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25)

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": "4fea0f23-dfda-444b-8206-ea7e5a078338", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0342543971066", "0342543970250", "0342543972063"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Strides Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25)", "package_ndc": "42543-970-25", "marketing_start_date": "20211222"}], "brand_name": "Hydrocortisone", "product_id": "42543-970_4fea0f23-dfda-444b-8206-ea7e5a078338", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "42543-970", "generic_name": "Hydrocortisone", "labeler_name": "Strides Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "ANDA207029", "marketing_category": "ANDA", "marketing_start_date": "20211222", "listing_expiration_date": "20271231"}