Hydromorphone Hydrochloride

Product NDC: 60687-579
11-digit product format: 606870579
Labeler code: 60687
Product ID: 60687-579_4bd4edc0-b58e-cd45-e063-6294a90a779c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076855
Marketing category: ANDA
Marketing start: 2021-05-11
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 2 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076855-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23
A076855-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19
A076855-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076855-001	AB
A076855-002	AB
A076855-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-002	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2007-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2007-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076855-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2004-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076855-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076855-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076855-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076855-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076855-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076855-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076855-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076855-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076855-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076855-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076855-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076855-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076855-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076855-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076855-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076855-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076855-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076855-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076855-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076855-001	AB	1	`8072bd15b7f6…`

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	2 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897696	Internal RxNorm lookup
897702	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
e4758743-9b2c-4612-8399-ad2db372e2b7	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
60687-579-01	Hydromorphone Hydrochloride	100 in 1 BOX, UNIT-DOSE	TABLET	100		6
60687-579-11	Hydromorphone Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-579-01	EA - Each	60687-579	a04f805c-940f-49ed-9b5a-8cfd2e405060	1	2021-06-02
60687-579-11	EA - Each	60687-579	2858995a-3852-4b78-b940-25324046d09f	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-579	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	5	Current NDC, Legacy NDC, 2 package rows	20250331_e4758743-9b2c-4612-8399-ad2db372e2b7.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
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	SpecGx LLC	4c5c1cc8-c42b-46e3-ad68-8e22f57101f2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076855 application number: ANDA076855
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	American Health Packaging	e4758743-9b2c-4612-8399-ad2db372e2b7	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076855 application number: ANDA076855 ndc (product): 60687-579

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
897696	HYDROmorphone HCl 2 MG Oral Tablet	PSN	e4758743-9b2c-4612-8399-ad2db372e2b7	6
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	e4758743-9b2c-4612-8399-ad2db372e2b7	6
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	e4758743-9b2c-4612-8399-ad2db372e2b7	6
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	e4758743-9b2c-4612-8399-ad2db372e2b7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-579-01	60687057901	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-579-01) / 1 TABLET in 1 BLISTER PACK (60687-579-11)	100 blister pack	2021-05-11	0000-00-00	No	No	Current
60687-579-11	60687057911	1 in 1 BLISTER PACK						Historical