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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 019034

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NDA 019034 describes DILAUDID-HP, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DILAUDID-HP profile page.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for 019034

Tradename:	DILAUDID-HP
Applicant:	Fresenius Kabi Usa
Ingredient:	hydromorphone hydrochloride
Patents:	2

Pharmacology for NDA: 019034

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019034

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 019034

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034	NDA	Fresenius Kabi USA, LLC	63323-851	63323-851-10	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)
DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034	NDA	Fresenius Kabi USA, LLC	63323-851	63323-851-10	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jan 11, 1984	TE:		RLD:	Yes
Patent:	9,248,229	Patent Expiration:	Mar 12, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,731,082	Patent Expiration:	Apr 23, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	250MG/VIAL
Approval Date:	Aug 4, 1994	TE:		RLD:	No
Patent:	9,248,229	Patent Expiration:	Mar 12, 2034	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 019034

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984	6,589,960	⤷ Get Started Free
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	6,589,960	⤷ Get Started Free
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960	⤷ Get Started Free
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	6,589,960	⤷ Get Started Free
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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