dexamethasone

Generic: dexamethasone

Labeler: marlex pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler marlex pharmaceuticals, inc
Dosage Form ELIXIR
Routes
ORAL
Active Ingredients

dexamethasone .5 mg/5mL

Manufacturer
Marlex Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 10135-795
Product ID 10135-795_59cae836-8f84-4276-9289-73ae101b8ddf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084754
Listing Expiration 2026-12-31
Marketing Start 1976-09-21

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 10135795
Hyphenated Format 10135-795

Supplemental Identifiers

RxCUI
309686
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 ANDA084754 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, GLASS (10135-795-71)
source: ndc

Packages (1)

10135-795-71 237 mL in 1 BOTTLE, GLASS (10135-795-71)

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": "59cae836-8f84-4276-9289-73ae101b8ddf", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["309686"], "spl_set_id": ["7b51ffce-ec64-4b49-8870-b9666537c541"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, GLASS (10135-795-71)", "package_ndc": "10135-795-71", "marketing_start_date": "19760921"}], "brand_name": "Dexamethasone", "product_id": "10135-795_59cae836-8f84-4276-9289-73ae101b8ddf", "dosage_form": "ELIXIR", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "10135-795", "generic_name": "Dexamethasone", "labeler_name": "Marlex Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".5 mg/5mL"}], "application_number": "ANDA084754", "marketing_category": "ANDA", "marketing_start_date": "19760921", "listing_expiration_date": "20261231"}