dexamethasone

Generic: dexamethasone

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler chartwell rx, llc
Dosage Form ELIXIR
Routes
ORAL
Active Ingredients

dexamethasone .5 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-114
Product ID 62135-114_13a14c37-eaf1-7848-e063-6394a90a5479
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091188
Listing Expiration 2026-12-31
Marketing Start 2011-05-11

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 62135114
Hyphenated Format 62135-114

Supplemental Identifiers

RxCUI
309686
UPC
0362135114374
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 ANDA091188 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (62135-114-37)
source: ndc

Packages (1)

62135-114-37 237 mL in 1 BOTTLE (62135-114-37)

Ingredients (1)

dexamethasone (.5 mg/5mL)

Linked Drug Pages (1)

Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13a14c37-eaf1-7848-e063-6394a90a5479", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362135114374"], "unii": ["7S5I7G3JQL"], "rxcui": ["309686"], "spl_set_id": ["3746066a-3c87-4238-945a-6dfb4d01a072"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (62135-114-37)", "package_ndc": "62135-114-37", "marketing_start_date": "20230113"}], "brand_name": "Dexamethasone", "product_id": "62135-114_13a14c37-eaf1-7848-e063-6394a90a5479", "dosage_form": "ELIXIR", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62135-114", "generic_name": "Dexamethasone", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".5 mg/5mL"}], "application_number": "ANDA091188", "marketing_category": "ANDA", "marketing_start_date": "20110511", "listing_expiration_date": "20261231"}