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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 040284

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NDA 040284 describes ORPHENADRINE CITRATE, which is a drug marketed by Hikma, Rising, Sagent Pharms, Watson Labs, Ascot, Lupin, Sandoz, Stevens J, and Unichem, and is included in fifteen NDAs. It is available from nineteen suppliers. Additional details are available on the ORPHENADRINE CITRATE profile page.

The generic ingredient in ORPHENADRINE CITRATE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.

Summary for 040284

Tradename:	ORPHENADRINE CITRATE
Applicant:	Lupin
Ingredient:	orphenadrine citrate
Patents:	0

Pharmacology for NDA: 040284

Physiological Effect	Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 040284

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040284	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-407	43063-407-14	14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14)
ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040284	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-407	43063-407-20	20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Jun 19, 1998	TE:	AB	RLD:	No

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