Application 076855

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	8MG	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	2MG	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	4MG	No	No

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…`

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 ndc (product): 0406-3243 ndc (product): 0406-3244 ndc (product): 0406-3249
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 ndc (product): 60687-590

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
60687-579	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
60687-579	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	American Health Packaging	ANDA	Current
60687-590	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
60687-590	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
67296-1414	Hydromorphone Hydrochloride	hydromorphone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
71335-0229	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0229	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0229	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0759	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0759	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76183	ORIG	2023-11-03