dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

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

dexamethasone .5 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-872
Product ID 70954-872_5d9b22ca-c619-4ee3-98eb-74544d0d5cb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084754
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

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 70954872
Hyphenated Format 70954-872

Supplemental Identifiers

RxCUI
309686
UPC
0370954872108
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
  • 1 BOTTLE in 1 CARTON (70954-872-10) / 237 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-872-10 1 BOTTLE in 1 CARTON (70954-872-10) / 237 mL in 1 BOTTLE

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": "5d9b22ca-c619-4ee3-98eb-74544d0d5cb3", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0370954872108"], "unii": ["7S5I7G3JQL"], "rxcui": ["309686"], "spl_set_id": ["5d9b22ca-c619-4ee3-98eb-74544d0d5cb3"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-872-10)  / 237 mL in 1 BOTTLE", "package_ndc": "70954-872-10", "marketing_start_date": "20251201"}], "brand_name": "Dexamethasone", "product_id": "70954-872_5d9b22ca-c619-4ee3-98eb-74544d0d5cb3", "dosage_form": "ELIXIR", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70954-872", "generic_name": "Dexamethasone", "labeler_name": "ANI 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": "20251201", "listing_expiration_date": "20261231"}