hydrocortisone

Generic: hydrocortisone

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler ani pharmaceuticals, inc.
Dosage Form ENEMA
Routes
RECTAL
Active Ingredients

hydrocortisone 100 mg/60mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-138
Product ID 62559-138_a1e01470-3da0-4ede-af39-2cdf8943f55f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA016199
Listing Expiration 2027-12-31
Marketing Start 2012-08-16

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 62559138
Hyphenated Format 62559-138

Supplemental Identifiers

RxCUI
310878
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 NDA016199 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/60mL
source: ndc
Packaging
  • 7 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11)
source: ndc

Packages (1)

62559-138-07 7 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11)

Ingredients (1)

hydrocortisone (100 mg/60mL)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "a1e01470-3da0-4ede-af39-2cdf8943f55f", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310878"], "spl_set_id": ["40654d12-56e4-4489-be49-19c60ad918ad"], "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": "7 BOTTLE in 1 BOX (62559-138-07)  / 60 mL in 1 BOTTLE (62559-138-11)", "package_ndc": "62559-138-07", "marketing_start_date": "20120816"}], "brand_name": "Hydrocortisone", "product_id": "62559-138_a1e01470-3da0-4ede-af39-2cdf8943f55f", "dosage_form": "ENEMA", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62559-138", "generic_name": "Hydrocortisone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "100 mg/60mL"}], "application_number": "NDA016199", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120816", "listing_expiration_date": "20271231"}