dexamethasone

Generic: dexamethasone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dexamethasone 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-582
Product ID 55289-582_2ac01b74-f082-65ff-e063-6394a90aa606
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084612
Listing Expiration 2026-12-31
Marketing Start 1978-07-19

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 55289582
Hyphenated Format 55289-582

Supplemental Identifiers

RxCUI
197582
UPC
0355289582106
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 ANDA084612 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (55289-582-04)
  • 6 TABLET in 1 BOTTLE, PLASTIC (55289-582-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (55289-582-10)
  • 15 TABLET in 1 BOTTLE, PLASTIC (55289-582-15)
  • 21 TABLET in 1 BOTTLE, PLASTIC (55289-582-21)
  • 28 TABLET in 1 BOTTLE, PLASTIC (55289-582-28)
source: ndc

Packages (6)

55289-582-04 4 TABLET in 1 BOTTLE, PLASTIC (55289-582-04) 55289-582-06 6 TABLET in 1 BOTTLE, PLASTIC (55289-582-06) 55289-582-10 10 TABLET in 1 BOTTLE, PLASTIC (55289-582-10) 55289-582-15 15 TABLET in 1 BOTTLE, PLASTIC (55289-582-15) 55289-582-21 21 TABLET in 1 BOTTLE, PLASTIC (55289-582-21) 55289-582-28 28 TABLET in 1 BOTTLE, PLASTIC (55289-582-28)

Ingredients (1)

dexamethasone (4 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": "2ac01b74-f082-65ff-e063-6394a90aa606", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0355289582106"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["89e1d458-7caa-430f-9c54-360889899a73"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (55289-582-04)", "package_ndc": "55289-582-04", "marketing_start_date": "20131021"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (55289-582-06)", "package_ndc": "55289-582-06", "marketing_start_date": "20131021"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (55289-582-10)", "package_ndc": "55289-582-10", "marketing_start_date": "20131021"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (55289-582-15)", "package_ndc": "55289-582-15", "marketing_start_date": "20131025"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (55289-582-21)", "package_ndc": "55289-582-21", "marketing_start_date": "20131021"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (55289-582-28)", "package_ndc": "55289-582-28", "marketing_start_date": "20131021"}], "brand_name": "Dexamethasone", "product_id": "55289-582_2ac01b74-f082-65ff-e063-6394a90aa606", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "55289-582", "generic_name": "Dexamethasone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA084612", "marketing_category": "ANDA", "marketing_start_date": "19780719", "listing_expiration_date": "20261231"}