HYDROMORPHONE HYDROCHLORIDE

Product NDC: 13107-107
11-digit product format: 131070107
Labeler code: 13107
Product ID: 13107-107_1c45740c-5fb6-4cf7-81b9-0865717334e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROMORPHONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma, LLC
Application: ANDA205814
Marketing category: ANDA
Marketing start: 2016-05-17
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205814-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13
A205814-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13
A205814-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205814-001	AB
A205814-002	AB
A205814-003	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	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2016-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205814-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2016-05-13	`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	A205814-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205814-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205814-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205814-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205814-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205814-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205814-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205814-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205814-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205814-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205814-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205814-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205814-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205814-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205814-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205814-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205814-001	AB	1	`8072bd15b7f6…`

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	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897696	Internal RxNorm lookup
897702	Internal RxNorm lookup
897710	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
f778dfab-e109-428e-b1b7-4dfb1b8293e4	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
13107-107-01	HYDROMORPHONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	7
13107-107-05	HYDROMORPHONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	7
13107-107-20	HYDROMORPHONE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET	20	7
13107-107-99	HYDROMORPHONE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-107-01	EA - Each	13107-107	9c81cc46-c927-45aa-8df4-8510f968a047	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-107	HYDROMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240706_f778dfab-e109-428e-b1b7-4dfb1b8293e4.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	Bryant Ranch Prepack	29765ff0-3b1d-47da-953e-28bf0e6a56ef	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205814 application number: ANDA205814
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	f778dfab-e109-428e-b1b7-4dfb1b8293e4	2023-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205814 application number: ANDA205814 ndc (product): 13107-107

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	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	f778dfab-e109-428e-b1b7-4dfb1b8293e4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-107-01	13107010701	100 TABLET in 1 BOTTLE (13107-107-01)	100 tablet	2016-05-17	0000-00-00	No	No	Current
13107-107-05	13107010705	500 TABLET in 1 BOTTLE (13107-107-05)	500 tablet	2016-05-17	0000-00-00	No	No	Current
13107-107-20	13107010720	20 TABLET in 1 BOTTLE (13107-107-20)	20 tablet	2016-05-17	0000-00-00	No	No	Current
13107-107-99	13107010799	1000 TABLET in 1 BOTTLE (13107-107-99)	1000 tablet	2016-05-17	0000-00-00	No	No	Current