dexamethasone

Generic: dexamethasone

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 1 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1706
Product ID 70771-1706_232c68af-fb83-4b93-9e16-9803c8e680c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216284
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

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 707711706
Hyphenated Format 70771-1706

Supplemental Identifiers

RxCUI
197579
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 ANDA216284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70771-1706-1)
source: ndc

Packages (1)

70771-1706-1 100 TABLET in 1 BOTTLE (70771-1706-1)

Ingredients (1)

dexamethasone (1 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": "232c68af-fb83-4b93-9e16-9803c8e680c0", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197579"], "spl_set_id": ["e9012a11-6219-4272-aea2-b7328bbcf523"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1706-1)", "package_ndc": "70771-1706-1", "marketing_start_date": "20240513"}], "brand_name": "Dexamethasone", "product_id": "70771-1706_232c68af-fb83-4b93-9e16-9803c8e680c0", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70771-1706", "generic_name": "Dexamethasone", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/1"}], "application_number": "ANDA216284", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}