dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 4 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3588
Product ID 68071-3588_3b2d9344-a30a-844a-e063-6294a90ae9f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215604
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

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 680713588
Hyphenated Format 68071-3588

Supplemental Identifiers

RxCUI
197582
UPC
0368071358865
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 ANDA215604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (68071-3588-1)
  • 6 TABLET in 1 BOTTLE (68071-3588-6)
  • 8 TABLET in 1 BOTTLE (68071-3588-8)
source: ndc

Packages (3)

68071-3588-1 10 TABLET in 1 BOTTLE (68071-3588-1) 68071-3588-6 6 TABLET in 1 BOTTLE (68071-3588-6) 68071-3588-8 8 TABLET in 1 BOTTLE (68071-3588-8)

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": "3b2d9344-a30a-844a-e063-6294a90ae9f4", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368071358865"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["141e16a7-1f3d-3943-e063-6294a90ac5a9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-3588-1)", "package_ndc": "68071-3588-1", "marketing_start_date": "20241202"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (68071-3588-6)", "package_ndc": "68071-3588-6", "marketing_start_date": "20240320"}, {"sample": false, "description": "8 TABLET in 1 BOTTLE (68071-3588-8)", "package_ndc": "68071-3588-8", "marketing_start_date": "20250730"}], "brand_name": "Dexamethasone", "product_id": "68071-3588_3b2d9344-a30a-844a-e063-6294a90ae9f4", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68071-3588", "generic_name": "Dexamethasone", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA215604", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}