Hydromorphone Hydrochloride

Product NDC: 60687-566
11-digit product format: 606870566
Labeler code: 60687
Product ID: 60687-566_51a03444-b8e6-9dca-e063-6394a90aba7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: NDA019891
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-09-01
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: Hydromorphone Hydrochloride
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897657	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
fab97112-e276-40e0-bc82-0a29d7fa75fa	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	SPL version
60687-566-40	Hydromorphone Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	4
60687-566-46	Hydromorphone Hydrochloride	10 in 1 TRAY	SOLUTION	10	4
60687-566-86	Hydromorphone Hydrochloride	3 in 1 CASE	SOLUTION	3	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-566-40	ML - Milliliter	60687-566	897667c7-ebbe-4469-9b67-e41605ea751c	1	2021-10-08
60687-566-46	ML - Milliliter	60687-566	d3a28f33-a2f6-4d19-aaf9-4c0c3336a3a4	1	2021-10-08
60687-566-86	ML - Milliliter	60687-566	4d4e0ecc-472c-4fdb-8448-986b1e95da3d	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-566	HYDROMORPHONE HYDROCHLORIDE SOLUTION [AMERICAN HEALTH PACKAGING]	3	Current NDC, Legacy NDC, 3 package rows	20240622_fab97112-e276-40e0-bc82-0a29d7fa75fa.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
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 ndc (product): 60687-566

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
897657	HYDROmorphone HCl 1 MG in 1 mL Oral Solution	PSN	fab97112-e276-40e0-bc82-0a29d7fa75fa	4
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	fab97112-e276-40e0-bc82-0a29d7fa75fa	4
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	fab97112-e276-40e0-bc82-0a29d7fa75fa	4
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	fab97112-e276-40e0-bc82-0a29d7fa75fa	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-566-40	60687056640	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
60687-566-46	60687056646	10 in 1 TRAY						Historical
60687-566-86	60687056686	3 TRAY in 1 CASE (60687-566-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-566-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-566-40)	3 tray	2021-09-30	0000-00-00	No	No	Current