Hydromorphone Hydrochloride

Product NDC: 43602-001
11-digit product format: 436020001
Labeler code: 43602
Product ID: 43602-001_c5abd799-51be-4368-b788-b6b6c30b90af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydromorphone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Ascent Pharmaceuticals Inc
Application: ANDA210176
Marketing category: ANDA
Marketing start: 2019-05-04
Substance: HYDROMORPHONE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210176-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2017-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210176-001	AA

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 2 · 41 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	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210176-001	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2017-10-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A210176-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210176-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210176-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210176-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210176-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210176-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210176-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210176-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210176-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210176-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210176-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210176-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210176-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210176-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210176-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210176-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210176-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210176-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210176-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210176-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210176-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210176-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210176-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210176-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210176-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210176-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210176-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210176-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210176-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210176-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210176-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210176-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210176-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210176-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210176-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210176-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210176-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210176-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210176-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210176-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydromorphone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	5 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897657	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
e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	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
43602-001-47	Hydromorphone Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-001	HYDROMORPHONE HYDROCHLORIDE SOLUTION [ASCENT PHARMACEUTICALS INC]	1	Current NDC, 1 package rows	20240830_e8fd7b0e-22b9-4f8a-8eb2-41d5031779af.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	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	2017-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210176 application number: ANDA210176 ndc (product): 43602-001

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
897657	HYDROmorphone HCl 1 MG in 1 mL Oral Solution	PSN	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	3
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	3
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	3
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	e8fd7b0e-22b9-4f8a-8eb2-41d5031779af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43602-001-47	43602000147	473 mL in 1 BOTTLE (43602-001-47)	473 ml	2019-05-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Ascent Pharmaceuticals Inc	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	2