dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

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

dexamethasone 4 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-914
Product ID 47781-914_f5d1d20f-dcb0-9ddf-b436-165cf014f5fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088481
Listing Expiration 2026-12-31
Marketing Start 2021-06-28

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 47781914
Hyphenated Format 47781-914

Supplemental Identifiers

RxCUI
197582 197583
UPC
0347781916015 0347781914011
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 ANDA088481 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (47781-914-01)
  • 10 BLISTER PACK in 1 CARTON (47781-914-51) / 10 TABLET in 1 BLISTER PACK (47781-914-13)
source: ndc

Packages (2)

47781-914-01 100 TABLET in 1 BOTTLE (47781-914-01) 47781-914-51 10 BLISTER PACK in 1 CARTON (47781-914-51) / 10 TABLET in 1 BLISTER PACK (47781-914-13)

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": "f5d1d20f-dcb0-9ddf-b436-165cf014f5fa", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0347781916015", "0347781914011"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582", "197583"], "spl_set_id": ["9ab26af9-8196-e3d3-76a3-75227fd4e1c3"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (47781-914-01)", "package_ndc": "47781-914-01", "marketing_start_date": "20210830"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (47781-914-51)  / 10 TABLET in 1 BLISTER PACK (47781-914-13)", "package_ndc": "47781-914-51", "marketing_start_date": "20210830"}], "brand_name": "Dexamethasone", "product_id": "47781-914_f5d1d20f-dcb0-9ddf-b436-165cf014f5fa", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "47781-914", "generic_name": "dexamethasone", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA088481", "marketing_category": "ANDA", "marketing_start_date": "20210628", "listing_expiration_date": "20261231"}