Hydromorphone Hydrochloride

Product NDC: 13811-701
11-digit product format: 138110701
Labeler code: 13811
Product ID: 13811-701_e22a1e07-ff84-4ef1-b154-804b49dcd52f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Trigen Laboratories, LLC
Application: ANDA205629
Marketing category: ANDA
Marketing start: 2016-09-15
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205629-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07
A205629-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07
A205629-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07
A205629-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07
A205629-005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205629-001	AB
A205629-002	AB
A205629-003	AB
A205629-004	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 5 · 173 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	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-005	HYDROMORPHONE HYDROCHLORIDE	24MG	TABLET, EXTENDED RELEASE / ORAL			2024-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-002	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-003	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-004	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205629-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-07-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A205629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205629-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205629-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205629-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205629-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205629-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205629-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205629-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205629-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205629-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205629-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205629-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205629-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205629-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205629-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydromorphone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	8 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
902729	Internal RxNorm lookup
902736	Internal RxNorm lookup
902741	Internal RxNorm lookup
1306898	Internal RxNorm lookup
2706360	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
8bb81796-6990-40e9-bee4-1f292f91ae99	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
13811-701-10	Hydromorphone Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13811-701-10	EA - Each	13811-701	c3f90f9b-c58c-419c-ad11-fee1d684553e	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13811-701	HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC]	26	Current NDC, Legacy NDC, 1 package rows	20250302_8bb81796-6990-40e9-bee4-1f292f91ae99.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Trigen Laboratories, LLC	8bb81796-6990-40e9-bee4-1f292f91ae99	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205629 application number: ANDA205629 ndc (product): 13811-701

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
902729	HYDROmorphone HCl 12 MG 24HR Extended Release Oral Tablet	PSN	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902736	HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet	PSN	8bb81796-6990-40e9-bee4-1f292f91ae99	29
1306898	HYDROmorphone HCl 32 MG 24HR Extended Release Oral Tablet	PSN	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902741	HYDROmorphone HCl 8 MG 24HR Extended Release Oral Tablet	PSN	8bb81796-6990-40e9-bee4-1f292f91ae99	29
2706360	HYDROmorphone hydrochloride 24 MG 24HR Extended Release Oral Tablet	PSN	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902729	24 HR hydromorphone hydrochloride 12 MG Extended Release Oral Tablet	SCD	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902736	24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet	SCD	8bb81796-6990-40e9-bee4-1f292f91ae99	29
2706360	24 HR hydromorphone hydrochloride 24 MG Extended Release Oral Tablet	SCD	8bb81796-6990-40e9-bee4-1f292f91ae99	29
1306898	24 HR hydromorphone hydrochloride 32 MG Extended Release Oral Tablet	SCD	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902741	24 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet	SCD	8bb81796-6990-40e9-bee4-1f292f91ae99	29
2706360	hydromorphone HCl 24 MG 24 HR Extended Release Oral Tablet	SY	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902729	hydromorphone hydrochloride 12 MG 24 HR Extended Release Oral Tablet	SY	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902736	hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet	SY	8bb81796-6990-40e9-bee4-1f292f91ae99	29
1306898	hydromorphone hydrochloride 32 MG 24 HR Extended Release Oral Tablet	SY	8bb81796-6990-40e9-bee4-1f292f91ae99	29
902741	hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral Tablet	SY	8bb81796-6990-40e9-bee4-1f292f91ae99	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13811-701-10	13811070110	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-701-10)	2016-09-15	0000-00-00	No	No	Current