Oxycodone Hydrochloride

Product NDC: 67296-2188
11-digit product format: 672962188
Labeler code: 67296
Product ID: 67296-2188_44f3146e-88e3-80e1-e063-6394a90a3a28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA077712
Marketing category: ANDA
Marketing start: 2024-09-10
Substance: OXYCODONE 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077712-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31
A077712-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31
A077712-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02
A077712-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13
A077712-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077712-001	AB
A077712-002	AB
A077712-003	AB
A077712-004	AB
A077712-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077712-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077712-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077712-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	AB	1	`03ed91905a0d…`

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: Oxycodone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE 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
C1ENJ2TE6C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049621	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
439c2de6-3ea5-e829-e063-6294a90aa77d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2188-1	Oxycodone Hydrochloride	12 in 1 BOTTLE, PLASTIC	TABLET	12		2

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Strides Pharma Science Limited	f3116ebf-d72c-4e98-aa50-006be4770c86	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	056bdaac-4a43-42f0-9435-f349d3ccc128	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Redpharm Drug	439c2de6-3ea5-e829-e063-6294a90aa77d	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712 ndc (product): 67296-2188
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	08977126-9671-4d87-9724-1599ca86e181	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3ca9f0d9-a40d-4416-e063-6394a90aec8b	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3245cd2f-8ad0-b755-e063-6394a90a603c	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3a849aeb-b72c-5cde-e063-6394a90a9768	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	32323565-5add-96a9-e063-6294a90a5b4e	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	323148b2-809a-db11-e063-6294a90abe36	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	439c2de6-3ea5-e829-e063-6294a90aa77d	2
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	439c2de6-3ea5-e829-e063-6294a90aa77d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2188-1	67296218801	12 TABLET in 1 BOTTLE, PLASTIC (67296-2188-1)	12 tablet	2024-09-10	No	No	Current