Dilaudid

Product NDC: 76045-010
11-digit product format: 760450010
Labeler code: 76045
Product ID: 76045-010_97bfcafb-2037-47dc-a0ae-f7b8007c47df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA019034
Marketing category: NDA
Marketing start: 2016-12-16
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76045-010		D	Discontinued by firm		2026-08-11
excluded package	package	76045-010	76045-010-10	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76045-010-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76045-010-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76045-010-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76045-010-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76045-010-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76045-010-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76045-010-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76045-010-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76045-010-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76045-010-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76045-010-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76045-010-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019034-001	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-01-11
N019034-002	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04
N019034-003	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-004	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-005	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30
N019034-006	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16
N019034-007	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N019034-001	AP
N019034-003	AP
N019034-004	AP
N019034-005	AP
N019034-006	AP
N019034-007	AP

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N019034-001	9731082	2032-04-23	Drug product	2018-02-05
N019034-001	9248229	2034-03-12	Drug product	2018-02-05
N019034-002	9731082	2032-04-23	Drug product	2018-02-05
N019034-002	9248229	2034-03-12	Drug product	2018-02-05
N019034-003	9731082	2032-04-23	Drug product	2018-02-05
N019034-003	9248229	2034-03-12	Drug product	2018-02-05
N019034-004	9731082	2032-04-23	Drug product	2018-02-05
N019034-004	9248229	2034-03-12	Drug product	2018-02-05
N019034-005	9731082	2032-04-23	Drug product	2018-02-05
N019034-005	9248229	2034-03-12	Drug product	2018-02-05
N019034-006	9731082	2032-04-23	Drug product	2023-05-23
N019034-006	9248229	2034-03-12	Drug product	2023-05-23
N019034-007	9731082	2032-04-23	Drug product	2018-02-05
N019034-007	9248229	2034-03-12	Drug product	2018-02-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 259 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-006	DILAUDID	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2020-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-007	DILAUDID	0.5MG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	2017-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-001	DILAUDID-HP	10MG/ML	INJECTABLE / INJECTION		RLD	1984-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-002	DILAUDID-HP	250MG/VIAL	INJECTABLE / INJECTION			1994-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-003	DILAUDID	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-004	DILAUDID	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-005	DILAUDID	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2009-04-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019034-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019034-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019034-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019034-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019034-007	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019034-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019034-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019034-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019034-006	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019034-007	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019034-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019034-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019034-005	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019034-006	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019034-007	AP	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 518 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	9731082	2032-04-23	Drug product	2018-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019034-007	9248229	2034-03-12	Drug product	2018-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	9731082	2032-04-23	Drug product	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019034-007	9248229	2034-03-12	Drug product	2018-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019034-001	9731082	2032-04-23	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-001	9248229	2034-03-12	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-002	9731082	2032-04-23	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-002	9248229	2034-03-12	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-003	9731082	2032-04-23	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-003	9248229	2034-03-12	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	9731082	2032-04-23	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-004	9248229	2034-03-12	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	9731082	2032-04-23	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-005	9248229	2034-03-12	Drug product	2018-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	9731082	2032-04-23	Drug product	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019034-006	9248229	2034-03-12	Drug product	2023-05-23	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dilaudid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L960UP2KRW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897756	Internal RxNorm lookup
897757	Internal RxNorm lookup
1433251	Internal RxNorm lookup
1872265	Internal RxNorm lookup
1872269	Internal RxNorm lookup
1872752	Internal RxNorm lookup
2277368	Internal RxNorm lookup
2277370	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9eebd88a-5632-460f-b7b6-26c8a180540d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c92985da-a658-b186-e763-2287eda87a86	Product name	3	20250221
96c475b3-58c7-b955-d715-0111804a3e50	Product name	5	20210512
1dd54659-b775-4fa8-a858-7f0e521fbadc	Product name	4	20200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76045-010-01	Dilaudid	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1		5
76045-010-11	Dilaudid	10 in 1 CARTON	INJECTION, SOLUTION	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76045-010-01	ML - Milliliter	76045-010	0d0b5ab9-5d03-453e-ad3c-0a47b4c9196f	1	2019-08-06
76045-010-10	ML - Milliliter	76045-010	0d19c7f7-dcd6-4bf5-9503-166ec768549a	1	2017-03-06
76045-010-11	ML - Milliliter	76045-010	dd348941-55c9-4613-a73c-977d9f3f8029	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76045-010	DILAUDID (HYDROMORPHONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC, 2 package rows	20240110_9eebd88a-5632-460f-b7b6-26c8a180540d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	9eebd88a-5632-460f-b7b6-26c8a180540d	2025-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019034 application number: NDA019034 ndc (product): 76045-010
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	e034eb96-03e0-46e1-8b92-5e1f94555e7b	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019034 application number: NDA019034

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE	71-68-1	HYDROMORPHONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2277370	Dilaudid 0.2 MG in 1 mL Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872752	Dilaudid 0.5 MG in 0.5 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872265	Dilaudid 1 MG in 1 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872269	Dilaudid 2 MG in 1 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1433251	HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897756	HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897757	HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277368	HYDROmorphone hydrochloride 0.2 MG in 1 mL Prefilled Syringe	PSN	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872752	0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe [Dilaudid]	SBD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277370	1 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe [Dilaudid]	SBD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872265	1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe [Dilaudid]	SBD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872269	1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe [Dilaudid]	SBD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1433251	0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277368	1 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe	SCD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897756	1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe	SCD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897757	1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe	SCD	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872752	0.5 ML Dilaudid 1 MG/ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277370	1 ML Dilaudid 0.2 MG/ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872265	1 ML Dilaudid 1 MG/ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872269	1 ML Dilaudid 2 MG/ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277370	Dilaudid 0.2 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872752	Dilaudid 0.5 MG per 0.5 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872265	Dilaudid 1 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1872269	Dilaudid 2 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
1433251	hydromorphone HCl 0.5 MG per 0.5 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897756	hydromorphone HCl 1 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
897757	hydromorphone HCl 2 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5
2277368	hydromorphone hydrochloride 0.2 MG per 1 ML Prefilled Syringe	SY	9eebd88a-5632-460f-b7b6-26c8a180540d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76045-010-01	76045001001	1 mL in 1 SYRINGE	1 ml					Historical
76045-010-10	76045001010	24 SYRINGE in 1 CARTON (76045-010-10) > 1 mL in 1 SYRINGE (76045-010-00)	24 syringe	2016-12-16	0000-00-00	No	No	Current
76045-010-11	76045001011	10 SYRINGE in 1 CARTON (76045-010-11) / 1 mL in 1 SYRINGE (76045-010-01)	10 syringe	2016-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dilaudid	Fresenius Kabi USA, LLC	2025-04-28	HUMAN PRESCRIPTION DRUG LABEL	5
Dilaudid	Fresenius Kabi USA, LLC	2021-01-27	HUMAN PRESCRIPTION DRUG LABEL	5