prednisone

Generic: prednisone

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 5 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-783
Product ID 64380-783_c389b525-c68a-43dc-bacc-c75707b391b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208412
Listing Expiration 2027-12-31
Marketing Start 2021-09-01

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 64380783
Hyphenated Format 64380-783

Supplemental Identifiers

RxCUI
198146 312617
UPC
0364380783060 0364380783084 0364380835066
UNII
VB0R961HZT
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 prednisone (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA208412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (64380-783-01) / 10 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-783-06)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (64380-783-08)
source: ndc

Packages (3)

64380-783-01 10 BLISTER PACK in 1 CARTON (64380-783-01) / 10 TABLET in 1 BLISTER PACK 64380-783-06 100 TABLET in 1 BOTTLE, PLASTIC (64380-783-06) 64380-783-08 1000 TABLET in 1 BOTTLE, PLASTIC (64380-783-08)

Ingredients (1)

prednisone (5 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": "c389b525-c68a-43dc-bacc-c75707b391b5", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0364380783060", "0364380783084", "0364380835066"], "unii": ["VB0R961HZT"], "rxcui": ["198146", "312617"], "spl_set_id": ["52010a34-aadb-4561-ac4a-3ee53f5e3566"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64380-783-01)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "64380-783-01", "marketing_start_date": "20210901"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-783-06)", "package_ndc": "64380-783-06", "marketing_start_date": "20210901"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (64380-783-08)", "package_ndc": "64380-783-08", "marketing_start_date": "20210901"}], "brand_name": "prednisone", "product_id": "64380-783_c389b525-c68a-43dc-bacc-c75707b391b5", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64380-783", "generic_name": "PREDNISONE", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA208412", "marketing_category": "ANDA", "marketing_start_date": "20210901", "listing_expiration_date": "20271231"}