prednisone

Generic: prednisone

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

Drug Facts

Product Profile

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

prednisone 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4191
Product ID 70518-4191_40948345-bcd5-cf1c-e063-6294a90a1725
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084122
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

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 705184191
Hyphenated Format 70518-4191

Supplemental Identifiers

RxCUI
198145
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 ANDA084122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-4191-1)
  • 10 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3)
  • 18 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4)
source: ndc

Packages (3)

70518-4191-1 30 TABLET in 1 BOTTLE, PLASTIC (70518-4191-1) 70518-4191-3 10 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3) 70518-4191-4 18 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4)

Ingredients (1)

prednisone (10 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": "40948345-bcd5-cf1c-e063-6294a90a1725", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145"], "spl_set_id": ["94715919-70bd-46c9-95fc-e151adf39cf9"], "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 BOTTLE, PLASTIC (70518-4191-1)", "package_ndc": "70518-4191-1", "marketing_start_date": "20240930"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3)", "package_ndc": "70518-4191-3", "marketing_start_date": "20241106"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4)", "package_ndc": "70518-4191-4", "marketing_start_date": "20250414"}], "brand_name": "PredniSONE", "product_id": "70518-4191_40948345-bcd5-cf1c-e063-6294a90a1725", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70518-4191", "generic_name": "PredniSONE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA084122", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}