dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

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

dexamethasone .75 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8763
Product ID 68788-8763_86f71920-d9ff-41d1-a70e-b90c446f6db6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216282
Listing Expiration 2027-12-31
Marketing Start 2024-11-11

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 687888763
Hyphenated Format 68788-8763

Supplemental Identifiers

RxCUI
343033
UNII
7S5I7G3JQL
NUI
N0000175576 N0000175450

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 ANDA216282 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8763-0)
  • 12 TABLET in 1 BOTTLE (68788-8763-1)
  • 21 TABLET in 1 BOTTLE (68788-8763-2)
  • 30 TABLET in 1 BOTTLE (68788-8763-3)
source: ndc

Packages (4)

Ingredients (1)

dexamethasone (.75 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "86f71920-d9ff-41d1-a70e-b90c446f6db6", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["343033"], "spl_set_id": ["64577454-d49e-4180-99e6-8461f74b0221"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8763-0)", "package_ndc": "68788-8763-0", "marketing_start_date": "20241111"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (68788-8763-1)", "package_ndc": "68788-8763-1", "marketing_start_date": "20241111"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (68788-8763-2)", "package_ndc": "68788-8763-2", "marketing_start_date": "20241111"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8763-3)", "package_ndc": "68788-8763-3", "marketing_start_date": "20241111"}], "brand_name": "Dexamethasone", "product_id": "68788-8763_86f71920-d9ff-41d1-a70e-b90c446f6db6", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68788-8763", "generic_name": "Dexamethasone", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".75 mg/1"}], "application_number": "ANDA216282", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20271231"}