alkindi sprinkle

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name alkindi sprinkle
Generic Name hydrocortisone
Labeler eton pharmaceuticals, inc.
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

hydrocortisone 1 mg/1

Manufacturer
Eton Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71863-110
Product ID 71863-110_47d0b789-3725-c6c5-e063-6394a90a9689
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213876
Listing Expiration 2027-12-31
Marketing Start 2020-09-29

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 71863110
Hyphenated Format 71863-110

Supplemental Identifiers

RxCUI
2399644 2399650 2399652 2399654 2399656 2399658 2399659 2399661
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 alkindi sprinkle (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number NDA213876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

71863-110-50 1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC

Ingredients (1)

hydrocortisone (1 mg/1)

Linked Drug Pages (1)

Alkindi Sprinkle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47d0b789-3725-c6c5-e063-6394a90a9689", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["2399644", "2399650", "2399652", "2399654", "2399656", "2399658", "2399659", "2399661"], "spl_set_id": ["26c13a5f-7119-4c6a-bf10-fda4e07d7682"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Eton Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50)  / 50 GRANULE in 1 BOTTLE, PLASTIC", "package_ndc": "71863-110-50", "marketing_start_date": "20200929"}], "brand_name": "Alkindi Sprinkle", "product_id": "71863-110_47d0b789-3725-c6c5-e063-6394a90a9689", "dosage_form": "GRANULE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71863-110", "generic_name": "Hydrocortisone", "labeler_name": "Eton Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alkindi", "brand_name_suffix": "Sprinkle", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 mg/1"}], "application_number": "NDA213876", "marketing_category": "NDA", "marketing_start_date": "20200929", "listing_expiration_date": "20271231"}