Oxymorphone hydrochloride

Product NDC: 55700-788
Requested package NDC: 55700-788-60
11-digit product format: 557000788
Labeler code: 55700
Product ID: 55700-788_1dd752f7-eb2e-4395-a646-418939def683
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxymorphone hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA079087
Marketing category: ANDA
Marketing start: 2019-08-30
Marketing end: 0000-00-00
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: 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	55700-788	55700-788-60	D	Discontinued by firm		2026-08-07

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-788-60	2025-01-10	C162847	48780-1	1030e364-fe3b-111a-e063-dadaa90a10e2	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
55700-788-60	2024-01-30	C162847	48780-1	1030e364-fe3b-111a-e063-dadaa90a10e2	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-788-60	EA - Each	55700-788	0b730637-5b2b-44bd-9597-07965768b50d	1	2019-10-07

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-788-60	55700078860	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-788-60)	2021-02-11	0000-00-00	No	No	Current