HYDROMORPHONE HYDROCHLORIDE

Product NDC: 13107-109
11-digit product format: 131070109
Labeler code: 13107
Product ID: 13107-109_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: 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 · 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 13107-109

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 · 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
13107-109-01	HYDROMORPHONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	7
13107-109-05	HYDROMORPHONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	7
13107-109-20	HYDROMORPHONE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET	20	7
13107-109-99	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
13107-109-01	EA - Each	13107-109	9a18b5a6-203a-4835-9fd6-82b484156e26	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-109	HYDROMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240706_f778dfab-e109-428e-b1b7-4dfb1b8293e4.zip

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
13107-109-01	13107010901	100 TABLET in 1 BOTTLE (13107-109-01)	100 tablet	2016-05-17	0000-00-00	No	No	Current
13107-109-05	13107010905	500 TABLET in 1 BOTTLE (13107-109-05)	500 tablet	2016-05-17	0000-00-00	No	No	Current
13107-109-20	13107010920	20 TABLET in 1 BOTTLE (13107-109-20)	20 tablet	2016-05-17	0000-00-00	No	No	Current
13107-109-99	13107010999	1000 TABLET in 1 BOTTLE (13107-109-99)	1000 tablet	2016-05-17	0000-00-00	No	No	Current