dexamethasone

Generic: dexamethasone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 4 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-3054
Product ID 71335-3054_015805cd-1e17-4e86-9a37-668597065f48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216282
Listing Expiration 2027-12-31
Marketing Start 2024-04-15

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 713353054
Hyphenated Format 71335-3054

Supplemental Identifiers

RxCUI
197582
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
  • 4 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE (71335-3054-0)
  • 30 TABLET in 1 BOTTLE (71335-3054-1)
  • 6 TABLET in 1 BOTTLE (71335-3054-2)
  • 3 TABLET in 1 BOTTLE (71335-3054-3)
  • 15 TABLET in 1 BOTTLE (71335-3054-4)
  • 40 TABLET in 1 BOTTLE (71335-3054-5)
  • 60 TABLET in 1 BOTTLE (71335-3054-6)
  • 28 TABLET in 1 BOTTLE (71335-3054-7)
  • 90 TABLET in 1 BOTTLE (71335-3054-8)
  • 10 TABLET in 1 BOTTLE (71335-3054-9)
source: ndc

Packages (10)

71335-3054-0 4 TABLET in 1 BOTTLE (71335-3054-0) 71335-3054-1 30 TABLET in 1 BOTTLE (71335-3054-1) 71335-3054-2 6 TABLET in 1 BOTTLE (71335-3054-2) 71335-3054-3 3 TABLET in 1 BOTTLE (71335-3054-3) 71335-3054-4 15 TABLET in 1 BOTTLE (71335-3054-4) 71335-3054-5 40 TABLET in 1 BOTTLE (71335-3054-5) 71335-3054-6 60 TABLET in 1 BOTTLE (71335-3054-6) 71335-3054-7 28 TABLET in 1 BOTTLE (71335-3054-7) 71335-3054-8 90 TABLET in 1 BOTTLE (71335-3054-8) 71335-3054-9 10 TABLET in 1 BOTTLE (71335-3054-9)

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": "015805cd-1e17-4e86-9a37-668597065f48", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["e830be9d-0a8c-4712-93c6-284c208d6f0d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE (71335-3054-0)", "package_ndc": "71335-3054-0", "marketing_start_date": "20260205"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-3054-1)", "package_ndc": "71335-3054-1", "marketing_start_date": "20260205"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (71335-3054-2)", "package_ndc": "71335-3054-2", "marketing_start_date": "20260205"}, {"sample": false, "description": "3 TABLET in 1 BOTTLE (71335-3054-3)", "package_ndc": "71335-3054-3", "marketing_start_date": "20260205"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71335-3054-4)", "package_ndc": "71335-3054-4", "marketing_start_date": "20260205"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (71335-3054-5)", "package_ndc": "71335-3054-5", "marketing_start_date": "20260205"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-3054-6)", "package_ndc": "71335-3054-6", "marketing_start_date": "20260205"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-3054-7)", "package_ndc": "71335-3054-7", "marketing_start_date": "20260205"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-3054-8)", "package_ndc": "71335-3054-8", "marketing_start_date": "20260205"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-3054-9)", "package_ndc": "71335-3054-9", "marketing_start_date": "20260205"}], "brand_name": "Dexamethasone", "product_id": "71335-3054_015805cd-1e17-4e86-9a37-668597065f48", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71335-3054", "generic_name": "Dexamethasone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA216282", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20271231"}