Hydromorphone Hydrochloride

Product NDC: 0054-0265
Requested package NDC: 0054-0265-25
11-digit product format: 000540265
Labeler code: 0054
Product ID: 0054-0265_6d31049c-2cef-4f8e-9e8b-2fd65c1e0b33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydromorphone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA074597
Marketing category: ANDA
Marketing start: 2009-07-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0054-0265	0054-0265-25	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074597-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL			1998-07-29
A074597-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL			2009-05-29

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 3 · 82 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	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL		1998-07-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL		2009-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074597-001	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET / ORAL	AB	1998-07-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074597-003	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2009-05-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074597-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074597-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074597-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074597-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074597-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074597-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074597-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074597-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074597-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074597-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074597-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074597-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074597-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074597-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074597-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074597-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074597-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074597-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074597-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074597-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074597-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074597-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074597-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074597-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074597-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074597-003	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074597-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074597-003	AB	1	`cb3db0bc1861…`

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
0054-0265-25	Hydromorphone Hydrochloride	100 in 1 BOTTLE	TABLET	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0265-25	EA - Each	0054-0265	c3fa7d12-686f-425d-9c68-e030dedb5f53	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	L960UP2KRW	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
HYDROMORPHONE	ACTIVE MOIETY	Q812464R06	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0265	HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	19	Legacy NDC, 1 package rows	20240308_cc574063-6ede-4da7-82c4-7450c92b229b.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	Hikma Pharmaceuticals USA Inc.	cc574063-6ede-4da7-82c4-7450c92b229b	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0054-0265-25 ndc (product): 0054-0265 ndc11 (package): 00054026525

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	cc574063-6ede-4da7-82c4-7450c92b229b	20
897702	HYDROmorphone HCl 4 MG Oral Tablet	PSN	cc574063-6ede-4da7-82c4-7450c92b229b	20
897710	HYDROmorphone HCl 8 MG Oral Tablet	PSN	cc574063-6ede-4da7-82c4-7450c92b229b	20
897657	hydromorphone hydrochloride 1 MG/ML Oral Solution	SCD	cc574063-6ede-4da7-82c4-7450c92b229b	20
897702	hydromorphone hydrochloride 4 MG Oral Tablet	SCD	cc574063-6ede-4da7-82c4-7450c92b229b	20
897710	hydromorphone hydrochloride 8 MG Oral Tablet	SCD	cc574063-6ede-4da7-82c4-7450c92b229b	20
897657	hydromorphone HCl 1 MG per 1 ML Oral Solution	SY	cc574063-6ede-4da7-82c4-7450c92b229b	20
897657	hydromorphone HCl 5 MG per 5 ML Oral Solution	SY	cc574063-6ede-4da7-82c4-7450c92b229b	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0265-25	00054026525	100 TABLET in 1 BOTTLE (0054-0265-25)	100 tablet	2009-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydromorphone Hydrochloride	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	20