Prednisone

Brand (proprietary) name

None — marketed under its generic name

Generic (nonproprietary) name

Prednisone

Active ingredient(s)

prednisone

Strength(s)

1 mg/1; 10 mg/1; 2.5 mg/1; 20 mg/1; 5 mg/1; 5 mg/5mL; 50 mg/1

Dosage form(s)

Solution; Tablet

Route(s)

Oral

Manufacturer / labeler

Hikma Pharmaceuticals USA Inc.Mylan Pharmaceuticals Inc.Actavis Pharma, Inc.Major PharmaceuticalsA-S Medication SolutionsAmerican Health PackagingChartwell RX, LLCStrides Pharma Science LimitedPreferred Pharmaceuticals Inc.PD-Rx Pharmaceuticals, Inc.

Product class

Generic (ANDA) (derived from FDA marketing category)

Marketing category

ANDA

Application number(s)

ANDA040256, ANDA040362, ANDA040392, ANDA040581, ANDA080292, ANDA080352, ANDA080356, ANDA083677, ANDA084275, ANDA084283, ANDA085161, ANDA085162, ANDA087801, ANDA088703, ANDA088832, ANDA208412, ANDA209727, ANDA210525, ANDA210785, ANDA211495, ANDA211496, ANDA211575, ANDA213385, ANDA213386, ANDA215672

Earliest marketing start

Apr 21, 1972

Products / packages indexed

89 / 259

FDA pharmacologic class: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]

Also searchable as: Prednisone · Ketorolac Tromethamine

Prescribing information on DailyMed (NLM)

• J7512JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveDerived calculation

  Prednisone, immediate release or delayed release, oral, 1 mg

  Derived: 214 of 259 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J7512. CMS quarters Q1 2021 – Q4 2026

  J-codes are permanent national codes for drugs and biologicals — most often clinician-administered (buy-and-bill) products paid under Medicare Part B — plus certain immunosuppressive, inhalation (via DME), and oral anticancer/antiemetic drugs. Units are reported in multiples of the dosage in the code descriptor.

Other drugs crosswalked to the same code(s)

• PredniSONE IntensolPredniSONE Intensol · J7512
• PredniSONE Tablets, USP, 10 mgPredniSONE · J7512
• PredniSONE Tablets, USP, 20 mgPredniSONE · J7512
• PredniSONE Tablets, USP, 5 mgPredniSONE · J7512

Which Medicare benefit pays for this drug?

• Coverage documents for prednisone NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “prednisone”. Covered diagnosis codes are listed in the articles.
• Coverage documents for J7512 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J7512”. Covered diagnosis codes are listed in the articles.

No current Medicare Billing and Coding article lists J7512.

• FDA NDC Directory data is submitted by labelers; FDA notes that inclusion does not mean the information was verified or that a product is approved, covered, or reimbursable.
• HCPCS links are derived from CMS NDC–HCPCS crosswalks, which support ASP-based Part B payment and are not a complete list of billable NDCs.
• Product class (brand, generic, biosimilar) is derived from the FDA marketing category and Purple Book license type, not from a commercial compendium.
• Payment limits are Medicare Part B national limits; they do not reflect payer contracts, OPPS rates, 340B pricing, or acquisition cost.
• Home infusion per diem S-codes are matched by therapy category from the FDA pharmacologic class and route, not from a CMS crosswalk. Payers choose which per diem codes they accept, and the right code can depend on the dosing schedule, infusion method, or daily volume.