Oxymorphone hydrochloride

Product NDC: 0115-1317
11-digit product format: 001151317
Labeler code: 0115
Product ID: 0115-1317_a8dc6624-df1e-4e5a-b445-9541658e3430
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxymorphone hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA079087
Marketing category: ANDA
Marketing start: 2013-01-02
Substance: OXYMORPHONE HYDROCHLORIDE
Active strength: 30 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

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1317-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1317-13	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1317-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1317-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0115-1317-03	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0115-1317-13	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0115-1317-01	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0115-1317-08	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A079087-001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14
A079087-002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21
A079087-003	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14
A079087-004	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21
A079087-005	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14
A079087-006	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22
A079087-007	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14

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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-006	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079087-007	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-006	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079087-007	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-006	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079087-007	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-006	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079087-007	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-006	OXYMORPHONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL		2010-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079087-007	OXYMORPHONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2010-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079087-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079087-002	OXYMORPHONE HYDROCHLORIDE	7.5MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079087-003	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079087-004	OXYMORPHONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079087-005	OXYMORPHONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL		2010-06-14	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079087-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079087-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079087-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079087-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079087-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079087-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A079087-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079087-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079087-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079087-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079087-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079087-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079087-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079087-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079087-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079087-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079087-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079087-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079087-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079087-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079087-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079087-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079087-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079087-006	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxymorphone hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMORPHONE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5Y2EI94NBC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
977874	Internal RxNorm lookup
977894	Internal RxNorm lookup
977902	Internal RxNorm lookup
977909	Internal RxNorm lookup
977915	Internal RxNorm lookup
977923	Internal RxNorm lookup
977929	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
557e9610-62d7-42bf-90c1-44215bd8c1f8	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0115-1317-01	2024-02-13	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-03	2024-02-13	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-08	2024-02-13	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-13	2024-02-13	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-01	2024-01-30	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-03	2024-01-30	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-08	2024-01-30	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-13	2024-01-30	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-01	2020-12-29	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-03	2020-12-29	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-08	2020-12-29	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-13	2020-12-29	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-01	2020-01-31	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-03	2020-01-31	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-08	2020-01-31	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1317-13	2020-01-31	These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0115-1317-01	Oxymorphone hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	40
0115-1317-03	Oxymorphone hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	40
0115-1317-08	Oxymorphone hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	40
0115-1317-13	Oxymorphone hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1317-01	EA - Each	0115-1317	1fc8b610-e1c5-4646-a199-15d3067e8935	1	2013-02-13
0115-1317-13	EA - Each	0115-1317	842f1ff9-acb9-4c47-bf6f-d61b93f194c4	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Oxymorphone hydrochloride	ACTIVE INGREDIENT	5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
Oxymorphone	ACTIVE MOIETY	9VXA968E0C	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
D&C red no. 27	INACTIVE INGREDIENT	2LRS185U6K	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
talc	INACTIVE INGREDIENT	7SEV7J4R1U	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1317	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	40	Current NDC, Legacy NDC, 4 package rows	20240215_557e9610-62d7-42bf-90c1-44215bd8c1f8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	3f4e703a-e398-42fd-8759-e398c79955f1	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079087 application number: ANDA079087
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	557e9610-62d7-42bf-90c1-44215bd8c1f8	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079087 application number: ANDA079087 ndc (product): 0115-1317

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
977874	oxyMORphone HCl 10 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977894	oxyMORphone HCl 15 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977902	oxyMORphone HCl 20 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977909	oxyMORphone HCl 30 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977915	oxyMORphone HCl 40 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977923	oxyMORphone HCl 5 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977929	oxyMORphone HCl 7.5 MG 12HR Extended Release Oral Tablet	PSN	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977874	12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977894	12 HR oxymorphone hydrochloride 15 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977902	12 HR oxymorphone hydrochloride 20 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977909	12 HR oxymorphone hydrochloride 30 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977915	12 HR oxymorphone hydrochloride 40 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977923	12 HR oxymorphone hydrochloride 5 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977929	12 HR oxymorphone hydrochloride 7.5 MG Extended Release Oral Tablet	SCD	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977874	oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977894	oxymorphone hydrochloride 15 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977902	oxymorphone hydrochloride 20 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977909	oxymorphone hydrochloride 30 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977915	oxymorphone hydrochloride 40 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977923	oxymorphone hydrochloride 5 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40
977929	oxymorphone hydrochloride 7.5 MG 12 HR Extended Release Oral Tablet	SY	557e9610-62d7-42bf-90c1-44215bd8c1f8	40

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1317-01	00115131701	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1317-01)	2013-01-02	0000-00-00	No	No	Current
0115-1317-03	00115131703	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1317-03)	2013-01-02	0000-00-00	No	No	Current
0115-1317-08	00115131708	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1317-08)	2013-01-02	0000-00-00	No	No	Current
0115-1317-13	00115131713	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1317-13)	2013-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	40
Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	2019-11-18	HUMAN PRESCRIPTION DRUG LABEL	10