hydrocortisone

Generic: hydrocortisone

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

Drug Facts

Product Profile

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

hydrocortisone 5 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-970
Product ID 64380-970_34a8b746-cc8c-4974-b60c-1b65049213dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207029
Listing Expiration 2027-12-31
Marketing Start 2020-09-25

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 64380970
Hyphenated Format 64380-970

Supplemental Identifiers

RxCUI
197782 197783 197787
UPC
0364380970255 0364380971061 0364380972068
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 (64380-970-25)
source: ndc

Packages (1)

64380-970-25 50 TABLET in 1 BOTTLE, PLASTIC (64380-970-25)

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": "34a8b746-cc8c-4974-b60c-1b65049213dd", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0364380970255", "0364380971061", "0364380972068"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197782", "197783", "197787"], "spl_set_id": ["90a46849-5b75-467b-9bc5-8f192d4d20d2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (64380-970-25)", "package_ndc": "64380-970-25", "marketing_start_date": "20200925"}], "brand_name": "Hydrocortisone", "product_id": "64380-970_34a8b746-cc8c-4974-b60c-1b65049213dd", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64380-970", "generic_name": "Hydrocortisone", "labeler_name": "Strides Pharma Science Limited", "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": "20200925", "listing_expiration_date": "20271231"}