Oxymorphone Hydrochloride

Product NDC: 10702-070
11-digit product format: 107020070
Labeler code: 10702
Product ID: 10702-070_499ffc26-7516-aea3-e063-6394a90a5845
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxymorphone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: KVK-Tech, Inc.
Application: ANDA203601
Marketing category: ANDA
Marketing start: 2013-02-11
Substance: OXYMORPHONE HYDROCHLORIDE
Active strength: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203601-001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30
A203601-002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203601-001	AB
A203601-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2013-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203601-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203601-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203601-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203601-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203601-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203601-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203601-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203601-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203601-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203601-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203601-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203601-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203601-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203601-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203601-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203601-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203601-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203601-002	AB	1	`782e0a99824c…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
977939	Internal RxNorm lookup
977942	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
dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	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	Strength	SPL version
10702-070-01	Oxymorphone Hydrochloride	100 in 1 BOTTLE	TABLET	100		17
10702-070-06	Oxymorphone Hydrochloride	60 in 1 BOTTLE	TABLET	60		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-070-01	EA - Each	10702-070	1c6cf187-f40d-4aec-b250-6ff2823c35e0	1	2013-03-03
10702-070-06	EA - Each	10702-070	eaa0ed22-d141-4760-99f9-8f1bc9c6cfb5	1	2019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
OXYMORPHONE	ACTIVE MOIETY	9VXA968E0C	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	3
OXYMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	5Y2EI94NBC	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
OXYMORPHONE	ACTIVE MOIETY	9VXA968E0C	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYMORPHONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-070	OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240118_dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b.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
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	KVK-Tech, Inc.	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203601 application number: ANDA203601 ndc (product): 10702-070

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	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	17
977939	oxyMORphone HCl 5 MG Oral Tablet	PSN	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	17
977942	oxymorphone hydrochloride 10 MG Oral Tablet	SCD	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	17
977939	oxymorphone hydrochloride 5 MG Oral Tablet	SCD	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-070-01	10702007001	100 TABLET in 1 BOTTLE (10702-070-01)	100 tablet	2013-02-11	0000-00-00	No	No	Current
10702-070-06	10702007006	60 TABLET in 1 BOTTLE (10702-070-06)	60 tablet	2018-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxymorphone Hydrochloride	KVK-Tech, Inc. \| KVK-TECH, INC \| KVK-TECH,Inc.	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	17
Oxymorphone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	8