Viewing data from:

DEMEROL

NDA

MEPERIDINE HYDROCHLORIDE | N021171 | HOSPIRA INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Demerol (2023)

Total Spending

$55K

Total Claims

7,198

Beneficiaries

4,189

ASP Price

—

HCPCS: J2175 — Injection, meperidine hydrochloride, per 100 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PENICK CORPInactiveMEPERIDINE HYDROCHLORIDE

DMF 80781989

MALLINCKRODT INCInactiveMEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML

DMF 116361995

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -63	View Letter (PDF)
Jan 8, 2025	SUPPL -60	View Letter (PDF)
Dec 19, 2023	SUPPL -53	View Letter (PDF)
Oct 9, 2019	SUPPL -32	View Letter (PDF)
Dec 20, 2016	SUPPL -24	View Letter (PDF)
Dec 20, 2016	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 75MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 100MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982