HYDROMORPHONE HYDROCHLORIDE

Product NDC: 43602-002
11-digit product format: 436020002
Labeler code: 43602
Product ID: 43602-002_b492adee-8ae4-476e-8047-c13fb2136b58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Ascent Pharmaceuticals Inc
Application: ANDA210506
Marketing category: ANDA
Marketing start: 2018-01-24
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
A210506-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17
A210506-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17
A210506-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210506-001	AB
A210506-002	AB
A210506-003	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	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-002	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2018-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-003	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	2018-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210506-001	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2018-01-17	`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	A210506-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210506-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210506-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210506-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210506-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210506-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210506-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210506-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210506-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210506-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210506-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210506-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210506-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210506-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210506-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210506-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210506-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210506-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210506-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210506-001	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
4de15afe-d676-4faa-a34d-9b9cb20dbf54	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
43602-002-05	HYDROMORPHONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500		1
43602-002-30	HYDROMORPHONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-002	HYDROMORPHONE HYDROCHLORIDE TABLET [ASCENT PHARMACEUTICALS INC]	1	Current NDC, 2 package rows	20240906_4de15afe-d676-4faa-a34d-9b9cb20dbf54.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	Ascent Pharmaceuticals Inc	4de15afe-d676-4faa-a34d-9b9cb20dbf54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210506 application number: ANDA210506 ndc (product): 43602-002

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	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1
897696	hydromorphone hydrochloride 2 MG Oral Tablet	SCD	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	4de15afe-d676-4faa-a34d-9b9cb20dbf54	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43602-002-05	43602000205	500 TABLET in 1 BOTTLE (43602-002-05)	500 tablet	2018-01-24	No	No	Current
43602-002-30	43602000230	30 TABLET in 1 BOTTLE (43602-002-30)	30 tablet	2018-01-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROMORPHONE HYDROCHLORIDE	Ascent Pharmaceuticals Inc	2024-09-04	HUMAN PRESCRIPTION DRUG LABEL	1