dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

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

dexamethasone 4 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1534
Product ID 70518-1534_494ba985-339a-97d9-e063-6294a90a2e24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084612
Listing Expiration 2027-12-31
Marketing Start 2018-10-15

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 705181534
Hyphenated Format 70518-1534

Supplemental Identifiers

RxCUI
197582
UNII
7S5I7G3JQL
NUI
N0000175576 N0000175450

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 ANDA084612 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-1534-0)
source: ndc

Packages (1)

70518-1534-0 30 TABLET in 1 BLISTER PACK (70518-1534-0)

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": "494ba985-339a-97d9-e063-6294a90a2e24", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["f5c9b70b-b835-4f3b-9643-0aec50a0d3f2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-1534-0)", "package_ndc": "70518-1534-0", "marketing_start_date": "20181015"}], "brand_name": "Dexamethasone", "product_id": "70518-1534_494ba985-339a-97d9-e063-6294a90a2e24", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70518-1534", "generic_name": "Dexamethasone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA084612", "marketing_category": "ANDA", "marketing_start_date": "20181015", "listing_expiration_date": "20271231"}