prednisone

Generic: prednisone

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 20 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1610
Product ID 67046-1610_41e71126-b6bf-cef1-e063-6394a90a800d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215672
Listing Expiration 2026-12-31
Marketing Start 2025-10-24

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 670461610
Hyphenated Format 67046-1610

Supplemental Identifiers

RxCUI
312615
UNII
VB0R961HZT
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 prednisone (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA215672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1610-3)
source: ndc

Packages (1)

67046-1610-3 30 TABLET in 1 BLISTER PACK (67046-1610-3)

Ingredients (1)

prednisone (20 mg/1)

Linked Drug Pages (1)

PREDNISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41e71126-b6bf-cef1-e063-6394a90a800d", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["312615"], "spl_set_id": ["41e6f1c3-d225-0ff0-e063-6394a90ace88"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1610-3)", "package_ndc": "67046-1610-3", "marketing_start_date": "20251024"}], "brand_name": "PREDNISONE", "product_id": "67046-1610_41e71126-b6bf-cef1-e063-6394a90a800d", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67046-1610", "generic_name": "PREDNISONE", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISONE", "active_ingredients": [{"name": "PREDNISONE", "strength": "20 mg/1"}], "application_number": "ANDA215672", "marketing_category": "ANDA", "marketing_start_date": "20251024", "listing_expiration_date": "20261231"}