Hydromorphone Hydrochloride

Product NDC: 0591-3739
11-digit product format: 005913739
Labeler code: 0591
Product ID: 0591-3739_58056dce-d482-4c10-abaf-6ecfd9f4f976
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA202144
Marketing category: ANDA
Marketing start: 2014-05-21
Marketing end: 2019-10-31
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 12 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0591-3739		D	Discontinued by firm	2026-10-05
excluded package	package	0591-3739	0591-3739-01	D	Discontinued by firm	2026-10-05
excluded package	package	0591-3739	0591-3739-10	D	Discontinued by firm	2026-10-05
excluded package	package	0591-3739	0591-3739-30	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-3739-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-3739-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-3739-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-3739-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-3739-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-3739-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-3739-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-3739-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-3739-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-3739-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-3739-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-3739-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-3739-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-3739-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-3739-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-3739-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-3739-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-3739-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-3739-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-3739-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-3739-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-3739-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-3739-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-3739-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-3739-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-3739-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-3739-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-3739-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-3739-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-3739-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-3739-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-3739-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-3739-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-3739-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-3739-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-3739-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202144-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12
A202144-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	2014-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202144-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	2016-06-30	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3739-01	EA - Each	0591-3739	409e9032-386e-4efc-9c3e-0cb4429ae577	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	10