Oxymorphone Hydrochloride

Product NDC: 0054-0284
11-digit product format: 000540284
Labeler code: 0054
Product ID: 0054-0284_8a79e4ba-019b-487c-8171-cdd021b7b986
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxymorphone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA090964
Marketing category: ANDA
Marketing start: 2010-09-27
Substance: OXYMORPHONE HYDROCHLORIDE
Active strength: 10 mg/1
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 44.

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
A090964-001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-09-27
A090964-002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090964-001	AB
A090964-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090964-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090964-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-09-27	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090964-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090964-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090964-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090964-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090964-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090964-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090964-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090964-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090964-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090964-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090964-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090964-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090964-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090964-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090964-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090964-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090964-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090964-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090964-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090964-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090964-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090964-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090964-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090964-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090964-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090964-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090964-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090964-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090964-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090964-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090964-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090964-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090964-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090964-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090964-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090964-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090964-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090964-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090964-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090964-002	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMORPHONE HYDROCHLORIDE	10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
52f0f025-f368-4487-8f9b-49af2656aeeb	Product name	3	20201015
3792daf4-c308-47ef-a996-98dc7faa1671	Product name	2	20150511
0476a93f-c9eb-691e-8ebf-e5b816d8f47b	Product name	1	20140508
a4b9889e-23ea-ee9f-05f6-4b861fda077b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0284-25	Oxymorphone Hydrochloride	100 in 1 BOTTLE	TABLET	100		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0284-25	EA - Each	0054-0284	eb18f3bb-3137-4174-9a2c-e51a184d98d5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
OXYMORPHONE	ACTIVE MOIETY	9VXA968E0C	OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYMORPHONE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
OXYMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
OXYMORPHONE	ACTIVE MOIETY	9VXA968E0C	OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYMORPHONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0284	OXYMORPHONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240203_3eb971cf-ab82-49f3-a46c-4d76a8ce599e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE	357-07-3	OXYMORPHONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
977942	oxyMORphone HCl 10 MG Oral Tablet	PSN	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	18
977939	oxyMORphone HCl 5 MG Oral Tablet	PSN	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	18
977942	oxymorphone hydrochloride 10 MG Oral Tablet	SCD	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	18
977939	oxymorphone hydrochloride 5 MG Oral Tablet	SCD	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	18
977942	oxyMORphone HCl 10 MG Oral Tablet	PSN	ce90be76-be31-4f81-aebb-ff60706bf8b4	1
977942	oxymorphone hydrochloride 10 MG Oral Tablet	SCD	ce90be76-be31-4f81-aebb-ff60706bf8b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0284-25	00054028425	100 TABLET in 1 BOTTLE (0054-0284-25)	100 tablet	2010-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxymorphone Hydrochloride	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	19
Oxymorphone Hydrochloride	Physicians Total Care, Inc.	2013-01-02	HUMAN PRESCRIPTION DRUG LABEL	1