Hydroxyprogesterone Caproate

Brand (proprietary) name

None — marketed under its generic name

Generic (nonproprietary) name

Hydroxyprogesterone Caproate

Active ingredient(s)

hydroxyprogesterone caproate

Strength(s)

1250 mg/5mL

Dosage form(s)

Injection

Route(s)

Intramuscular

Manufacturer / labeler

American Regent, Inc.Eugia US LLCPrasco LaboratoriesMylan Institutional LLCAmneal Pharmaceuticals of NY LLCSlayback Pharma LLC

Product class

Authorized generic (derived from FDA marketing category)

Marketing category

ANDA; NDA AUTHORIZED GENERIC

Application number(s)

ANDA200271, ANDA210618, ANDA210723, ANDA210877, ANDA211070, ANDA211071, ANDA211142, ANDA211777, NDA021945

Earliest marketing start

Sep 22, 2017

Products / packages indexed

12 / 13

FDA pharmacologic class: Progesterone Congeners [CS]; Progestin [EPC]

Also searchable as: Hydroxyprogesterone Caproate · MAKENA

Prescribing information on DailyMed (NLM)

• J1726JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveDerived calculation

  Injection, hydroxyprogesterone caproate, (makena), 10 mg

  Derived: 11 of 13 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J1726. CMS quarters Q1 2021 – Q2 2025Not in the latest CMS crosswalk.

  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.

No authoritative public data was located for this field.

Home infusion per diem (S-codes)

Medicare

Not payable by Medicare — CMS coverage code I (all 2 codes)

Part B pricing indicator

00 — Not separately priced by Part B (all 2 codes)

National payment amount

Other drugs crosswalked to the same code(s)

• Makena · J1726

Which Medicare benefit pays for this drug?

• Coverage documents for hydroxyprogesterone caproate NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “hydroxyprogesterone caproate”. Covered diagnosis codes are listed in the articles.
• Coverage documents for J1726 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J1726”. Covered diagnosis codes are listed in the articles.

No current Medicare Billing and Coding article lists J1726.

• 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.