hydrocortisone

Generic: hydrocortisone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrocortisone 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1989
Product ID 71335-1989_54e94095-73b5-4dfc-a0f7-1b97ea861f37
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 713351989
Hyphenated Format 71335-1989

Supplemental Identifiers

RxCUI
197787
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (71335-1989-1)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71335-1989-2)
  • 58 TABLET in 1 BOTTLE, PLASTIC (71335-1989-3)
  • 28 TABLET in 1 BOTTLE, PLASTIC (71335-1989-4)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71335-1989-5)
  • 100 TABLET in 1 BOTTLE, PLASTIC (71335-1989-6)
source: ndc

Packages (6)

71335-1989-1 30 TABLET in 1 BOTTLE, PLASTIC (71335-1989-1) 71335-1989-2 90 TABLET in 1 BOTTLE, PLASTIC (71335-1989-2) 71335-1989-3 58 TABLET in 1 BOTTLE, PLASTIC (71335-1989-3) 71335-1989-4 28 TABLET in 1 BOTTLE, PLASTIC (71335-1989-4) 71335-1989-5 60 TABLET in 1 BOTTLE, PLASTIC (71335-1989-5) 71335-1989-6 100 TABLET in 1 BOTTLE, PLASTIC (71335-1989-6)

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": "54e94095-73b5-4dfc-a0f7-1b97ea861f37", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["197787"], "spl_set_id": ["47bfae62-bf25-413e-93fc-3c72c901f1a5"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71335-1989-1)", "package_ndc": "71335-1989-1", "marketing_start_date": "20240718"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71335-1989-2)", "package_ndc": "71335-1989-2", "marketing_start_date": "20240718"}, {"sample": false, "description": "58 TABLET in 1 BOTTLE, PLASTIC (71335-1989-3)", "package_ndc": "71335-1989-3", "marketing_start_date": "20240718"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (71335-1989-4)", "package_ndc": "71335-1989-4", "marketing_start_date": "20240718"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71335-1989-5)", "package_ndc": "71335-1989-5", "marketing_start_date": "20211111"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (71335-1989-6)", "package_ndc": "71335-1989-6", "marketing_start_date": "20240718"}], "brand_name": "HYDROCORTISONE", "product_id": "71335-1989_54e94095-73b5-4dfc-a0f7-1b97ea861f37", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71335-1989", "generic_name": "hydrocortisone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "5 mg/1"}], "application_number": "ANDA040646", "marketing_category": "ANDA", "marketing_start_date": "20070330", "listing_expiration_date": "20261231"}