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 50 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-949
Product ID 64380-949_bdf0b63b-7d6e-4799-be31-cdbf94e02145
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208412
Listing Expiration 2027-12-31
Marketing Start 2022-05-24

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 64380949
Hyphenated Format 64380-949

Supplemental Identifiers

RxCUI
198145 198148 312615
UPC
0364380949060 0364380785064 0364380784067
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
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (64380-949-01) / 10 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE (64380-949-06)
source: ndc

Packages (2)

64380-949-01 10 BLISTER PACK in 1 CARTON (64380-949-01) / 10 TABLET in 1 BLISTER PACK 64380-949-06 100 TABLET in 1 BOTTLE (64380-949-06)

Ingredients (1)

prednisone (50 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": "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0364380949060", "0364380785064", "0364380784067"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "198148", "312615"], "spl_set_id": ["2ef05381-faad-4e0f-b58d-9f2236a04a2c"], "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 (64380-949-01)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "64380-949-01", "marketing_start_date": "20220524"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-949-06)", "package_ndc": "64380-949-06", "marketing_start_date": "20220524"}], "brand_name": "prednisone", "product_id": "64380-949_bdf0b63b-7d6e-4799-be31-cdbf94e02145", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64380-949", "generic_name": "PREDNISONE", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "50 mg/1"}], "application_number": "ANDA208412", "marketing_category": "ANDA", "marketing_start_date": "20220524", "listing_expiration_date": "20271231"}