Dilaudid

Product NDC: 42858-416
11-digit product format: 428580416
Labeler code: 42858
Product ID: 42858-416_3348b431-907c-4f1d-8a18-e4be2a04df23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: NDA019891
Marketing category: NDA
Marketing start: 2017-05-15
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dilaudid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	5 mg/5mL

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
897657	Internal RxNorm lookup
897658	Internal RxNorm lookup
897696	Internal RxNorm lookup
897698	Internal RxNorm lookup
897702	Internal RxNorm lookup
897704	Internal RxNorm lookup
897710	Internal RxNorm lookup
897712	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
d6b40e39-a57e-402c-b4f6-7041e832f837	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
42858-416-16	Dilaudid	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-416-16	ML - Milliliter	42858-416	94999a97-2b48-41b4-8296-e9e46d45b7d2	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-416	DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET DILAUDID (HYDROMORPHONE HYDROCHLORIDE) SOLUTION [RHODES PHARMACEUTICALS L.P.]	9	Current NDC, Legacy NDC, 1 package rows	20240110_d6b40e39-a57e-402c-b4f6-7041e832f837.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 · 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
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

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
897658	Dilaudid 1 MG in 1 mL Oral Solution	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897698	DILAUDID 2 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897704	DILAUDID 4 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897712	DILAUDID 8 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897657	HYDROmorphone HCl 1 MG in 1 mL Oral Solution	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897696	HYDROmorphone HCl 2 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897658	hydromorphone hydrochloride 1 MG/ML Oral Solution [Dilaudid]	SBD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897698	hydromorphone hydrochloride 2 MG Oral Tablet [Dilaudid]	SBD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897704	hydromorphone hydrochloride 4 MG Oral Tablet [Dilaudid]	SBD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897712	hydromorphone hydrochloride 8 MG Oral Tablet [Dilaudid]	SBD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897658	Dilaudid 1 MG per 1 ML Oral Solution	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897658	Dilaudid 1 MG/ML Oral Solution	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897698	Dilaudid 2 MG Oral Tablet	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897704	Dilaudid 4 MG Oral Tablet	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897712	Dilaudid 8 MG Oral Tablet	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	d6b40e39-a57e-402c-b4f6-7041e832f837	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-416-16	42858041616	473 mL in 1 BOTTLE, PLASTIC (42858-416-16)	473 ml	2017-05-15	0000-00-00	No	No	Current