prednisone

Generic: prednisone

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

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 10 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-777
Product ID 10135-777_441fcae7-8682-1a29-e063-6394a90a3881
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211575
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 10135777
Hyphenated Format 10135-777

Supplemental Identifiers

RxCUI
198145 198146 198148 312615 312617
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 ANDA211575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-777-01)
  • 1000 TABLET in 1 BOTTLE (10135-777-10)
source: ndc

Packages (2)

10135-777-01 100 TABLET in 1 BOTTLE (10135-777-01) 10135-777-10 1000 TABLET in 1 BOTTLE (10135-777-10)

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": "441fcae7-8682-1a29-e063-6394a90a3881", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "198146", "198148", "312615", "312617"], "spl_set_id": ["f499197b-b9b7-1707-e053-2a95a90a0932"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-777-01)", "package_ndc": "10135-777-01", "marketing_start_date": "20230201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10135-777-10)", "package_ndc": "10135-777-10", "marketing_start_date": "20230201"}], "brand_name": "Prednisone", "product_id": "10135-777_441fcae7-8682-1a29-e063-6394a90a3881", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "10135-777", "generic_name": "Prednisone", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA211575", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}