Application 019034

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	Yes	No
002	DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	250MG/VIAL	No	No
003	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	Yes	Yes
004	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	2MG/ML	Yes	Yes
005	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	4MG/ML	Yes	No
006	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.2MG/ML	Yes	Yes
007	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5MG/0.5ML	Yes	Yes

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…`

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): 76045-009 ndc (product): 76045-121 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 ndc (product): 63323-854 ndc (product): 63323-853 ndc (product): 63323-851 ndc (product): 63323-852

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59011-442	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
59011-444	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
63323-851	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-851	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-851	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-852	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-852	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-852	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-853	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-853	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-853	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-854	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-854	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
63323-854	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-009	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-009	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-009	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-009	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-009	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-010	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-010	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-010	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-010	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-010	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-121	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current
76045-121	Dilaudid	Hydromorphone hydrochloride	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84707	SUPPL	2026-01-07
84558	SUPPL	2025-12-29
76981	SUPPL	2023-12-19
76886	SUPPL	2023-12-18
74171	SUPPL	2023-05-04
60299	SUPPL	2019-10-08
60280	SUPPL	2019-10-07
47246	SUPPL	2017-02-16
46507	SUPPL	2016-12-23
46402	SUPPL	2016-12-21
46221	SUPPL	2016-12-19
33692	SUPPL	2011-07-06
1211	SUPPL	2011-07-06
11421	SUPPL	2009-05-11
1210	SUPPL	2009-05-06
16180	SUPPL	2006-06-12
11420	SUPPL	2006-06-12