Application 019891

Type: NDA
Sponsor: RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019891-001	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019891-001	AA

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 2 · 41 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	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019891-001	DILAUDID	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	1992-12-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N019891-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019891-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019891-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019891-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019891-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019891-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019891-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019891-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019891-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019891-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019891-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019891-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019891-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019891-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019891-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019891-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019891-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019891-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019891-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019891-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019891-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019891-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019891-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019891-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019891-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019891-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019891-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019891-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019891-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019891-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019891-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019891-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019891-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019891-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019891-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019891-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019891-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019891-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019891-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019891-001	AA	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019891-001	6589960	2020-11-09	Drug substance, Drug product	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dilaudid	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	d6b40e39-a57e-402c-b4f6-7041e832f837	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019891 application number: NDA019891 ndc (product): 42858-416
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	37565441-0d95-4743-a695-d7b3326f58a1	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019891 application number: NDA019891 ndc (product): 42858-304
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	American Health Packaging	fab97112-e276-40e0-bc82-0a29d7fa75fa	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019891 application number: NDA019891 ndc (product): 60687-566

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-304	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-304	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-304	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-304	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-416	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-416	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-416	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-416	Dilaudid	hydromorphone hydrochloride	Rhodes Pharmaceuticals L.P.	NDA	Current
59011-451	DILAUDID	HYDROMORPHONE HYDROCHLORIDE	Purdue Pharma LP	NDA	Current
60687-566	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84682	SUPPL	2026-01-06
84590	SUPPL	2025-12-29
80089	SUPPL	2024-11-04
76994	SUPPL	2023-12-19
76893	SUPPL	2023-12-18
76892	SUPPL	2023-12-18
76227	ORIG	2023-11-03
66516	SUPPL	2021-03-05
66515	SUPPL	2021-03-05
66507	SUPPL	2021-03-05
60353	SUPPL	2019-10-08
60315	SUPPL	2019-10-08
60314	SUPPL	2019-10-08
55657	SUPPL	2018-09-28
55656	SUPPL	2018-09-28
55603	SUPPL	2018-09-24
55602	SUPPL	2018-09-24
46392	SUPPL	2016-12-21
46239	SUPPL	2016-12-20
19798	SUPPL	2006-06-12
11820	SUPPL	2006-06-12