Oxymorphone hydrochloride

Product NDC: 64896-696
11-digit product format: 648960696
Labeler code: 64896
Product ID: 64896-696_4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxymorphone hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA079087
Marketing category: ANDA
Marketing start: 2013-01-02
Substance: OXYMORPHONE HYDROCHLORIDE
Active strength: 7.5 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 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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMORPHONE HYDROCHLORIDE	7.5 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
3f4e703a-e398-42fd-8759-e398c79955f1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64896-696-01	Oxymorphone hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	15
64896-696-03	Oxymorphone hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	15
64896-696-08	Oxymorphone hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	15
64896-696-13	Oxymorphone hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64896-696-01	EA - Each	64896-696	f6166217-45d5-47b3-8caf-c535ab16ae70	1	2019-07-02
64896-696-13	EA - Each	64896-696	4c37a560-02f1-4f14-834f-3fb87a9ff8a7	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64896-696	OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	8	Current NDC, Legacy NDC, 4 package rows	20241025_3f4e703a-e398-42fd-8759-e398c79955f1.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 ndc (product): 64896-696
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

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	3f4e703a-e398-42fd-8759-e398c79955f1	15
977894	oxyMORphone HCl 15 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977902	oxyMORphone HCl 20 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977909	oxyMORphone HCl 30 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977915	oxyMORphone HCl 40 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977923	oxyMORphone HCl 5 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977929	oxyMORphone HCl 7.5 MG 12HR Extended Release Oral Tablet	PSN	3f4e703a-e398-42fd-8759-e398c79955f1	15
977874	12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977894	12 HR oxymorphone hydrochloride 15 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977902	12 HR oxymorphone hydrochloride 20 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977909	12 HR oxymorphone hydrochloride 30 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977915	12 HR oxymorphone hydrochloride 40 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977923	12 HR oxymorphone hydrochloride 5 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977929	12 HR oxymorphone hydrochloride 7.5 MG Extended Release Oral Tablet	SCD	3f4e703a-e398-42fd-8759-e398c79955f1	15
977874	oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977894	oxymorphone hydrochloride 15 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977902	oxymorphone hydrochloride 20 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977909	oxymorphone hydrochloride 30 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977915	oxymorphone hydrochloride 40 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977923	oxymorphone hydrochloride 5 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15
977929	oxymorphone hydrochloride 7.5 MG 12 HR Extended Release Oral Tablet	SY	3f4e703a-e398-42fd-8759-e398c79955f1	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64896-696-01	64896069601	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-01)	2013-01-02	0000-00-00	No	No	Current
64896-696-03	64896069603	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-03)	2013-01-02	0000-00-00	No	No	Current
64896-696-08	64896069608	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-08)	2013-01-02	0000-00-00	No	No	Current
64896-696-13	64896069613	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-13)	2013-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	15