cortenema

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name cortenema
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 62559-111
Product ID 62559-111_45040499-9056-45bd-9e0f-113b619fc6ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016199
Listing Expiration 2027-12-31
Marketing Start 2012-08-10

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 62559111
Hyphenated Format 62559-111

Supplemental Identifiers

RxCUI
102250 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 cortenema (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, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE
  • 1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE
source: ndc

Packages (2)

62559-111-07 7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE 62559-111-11 1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE

Ingredients (1)

hydrocortisone (100 mg/60mL)

Linked Drug Pages (1)

Cortenema ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "45040499-9056-45bd-9e0f-113b619fc6ca", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["102250", "310878"], "spl_set_id": ["a307448a-ccc4-41a8-977a-11f28f0bded9"], "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, UNIT-DOSE in 1 CARTON (62559-111-07)  / 60 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "62559-111-07", "marketing_start_date": "20120810"}, {"sample": false, "description": "1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11)  / 60 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "62559-111-11", "marketing_start_date": "20120810"}], "brand_name": "Cortenema", "product_id": "62559-111_45040499-9056-45bd-9e0f-113b619fc6ca", "dosage_form": "ENEMA", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62559-111", "generic_name": "Hydrocortisone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cortenema", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "100 mg/60mL"}], "application_number": "NDA016199", "marketing_category": "NDA", "marketing_start_date": "20120810", "listing_expiration_date": "20271231"}