dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 1.5 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-401
Product ID 70954-401_75141974-8862-4da7-9253-a338cb1fdb84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215604
Listing Expiration 2026-12-31
Marketing Start 2022-08-08

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 70954401
Hyphenated Format 70954-401

Supplemental Identifiers

RxCUI
197577 197580 197581 197582 197583 343033
UPC
0370954399100 0370954404101 0370954402107 0370954403104 0370954401100 0370954398103
UNII
7S5I7G3JQL
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 dexamethasone (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number ANDA215604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-401-10)
source: ndc

Packages (1)

70954-401-10 100 TABLET in 1 BOTTLE (70954-401-10)

Ingredients (1)

dexamethasone (1.5 mg/1)

Linked Drug Pages (1)

Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "75141974-8862-4da7-9253-a338cb1fdb84", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0370954399100", "0370954404101", "0370954402107", "0370954403104", "0370954401100", "0370954398103"], "unii": ["7S5I7G3JQL"], "rxcui": ["197577", "197580", "197581", "197582", "197583", "343033"], "spl_set_id": ["fe8cf911-84ef-47be-acb8-0501b546299b"], "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": "100 TABLET in 1 BOTTLE (70954-401-10)", "package_ndc": "70954-401-10", "marketing_start_date": "20220808"}], "brand_name": "Dexamethasone", "product_id": "70954-401_75141974-8862-4da7-9253-a338cb1fdb84", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70954-401", "generic_name": "Dexamethasone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1.5 mg/1"}], "application_number": "ANDA215604", "marketing_category": "ANDA", "marketing_start_date": "20220808", "listing_expiration_date": "20261231"}