hydrocortisone sodium succinate (69097-004)

Drug Facts

Product Profile

Brand Name hydrocortisone sodium succinate

Generic Name hydrocortisone sodium succinate

Labeler cipla usa inc.

Dosage Form INJECTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

hydrocortisone sodium succinate 100 mg/2mL

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-004

Product ID 69097-004_44159bea-88a1-49ac-a51e-1c27dc89d9ff

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214050

Listing Expiration 2026-12-31

Marketing Start 2024-09-25

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097004

Hyphenated Format 69097-004

Supplemental Identifiers

RxCUI

238755

UNII

50LQB69S1Z

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 sodium succinate (source: ndc)

Generic Name hydrocortisone sodium succinate (source: ndc)

Application Number ANDA214050 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/2mL

source: ndc

Packaging

1 VIAL in 1 CARTON (69097-004-67) / 2 mL in 1 VIAL

source: ndc

Packages (1)

69097-004-67 1 VIAL in 1 CARTON (69097-004-67) / 2 mL in 1 VIAL

Ingredients (1)

hydrocortisone sodium succinate (100 mg/2mL)

Linked Drug Pages (1)

Hydrocortisone sodium succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "44159bea-88a1-49ac-a51e-1c27dc89d9ff", "openfda": {"unii": ["50LQB69S1Z"], "rxcui": ["238755"], "spl_set_id": ["451d6d04-b7d9-47d9-ba71-43cc5b9b3054"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (69097-004-67)  / 2 mL in 1 VIAL", "package_ndc": "69097-004-67", "marketing_start_date": "20240925"}], "brand_name": "Hydrocortisone sodium succinate", "product_id": "69097-004_44159bea-88a1-49ac-a51e-1c27dc89d9ff", "dosage_form": "INJECTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69097-004", "generic_name": "Hydrocortisone sodium succinate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone sodium succinate", "active_ingredients": [{"name": "HYDROCORTISONE SODIUM SUCCINATE", "strength": "100 mg/2mL"}], "application_number": "ANDA214050", "marketing_category": "ANDA", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}