Oxycodone Hydrochloride

Product NDC: 42858-001
11-digit product format: 428580001
Labeler code: 42858
Product ID: 42858-001_d95a9c89-1435-4594-be8b-e19e23d07c0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: ANDA091490
Marketing category: ANDA
Marketing start: 2014-09-08
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: 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091490-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09
A091490-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09
A091490-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09
A091490-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09
A091490-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091490-001	AB
A091490-002	AB
A091490-003	AB
A091490-004	AB
A091490-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2011-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-03-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A091490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091490-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091490-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091490-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091490-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091490-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091490-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091490-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091490-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone Hydrochloride
Listing expiration: 2027-12-31

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049611	Internal RxNorm lookup
1049618	Internal RxNorm lookup
1049621	Internal RxNorm lookup
1049683	Internal RxNorm lookup
1049686	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
a5162476-1217-41c0-bc7e-0a0f123f069f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
42858-001-01	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-01	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-01	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-08-16	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-01	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-01	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-01	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-10	2022-07-29	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42858-001-01	Oxycodone Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	26
42858-001-10	Oxycodone Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	26
42858-001-10	Oxycodone Hydrochloride	10 in 1 CARTON	TABLET	10	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-001-01	EA - Each	42858-001	aa9c4aed-463b-4b77-8118-42db34a6f852	1	2014-09-03
42858-001-10	EA - Each	42858-001	3372a3d4-7bb6-448d-8040-b8aaec5fac36	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-001	OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]	22	Current NDC, Legacy NDC, 3 package rows	20240430_a5162476-1217-41c0-bc7e-0a0f123f069f.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	bb33bf7f-aa70-4e8a-91b2-4e0400dc328e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	0e4dd113-87ab-4a5d-846a-446db3cfd469	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	a5162476-1217-41c0-bc7e-0a0f123f069f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490 ndc (product): 42858-001
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	6de58d48-d6fc-46b4-ab7c-9ffdede855dc	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	a1e539ba-2cb5-4815-8c58-37abfd978fa5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	7503ef9d-0fad-421f-951a-f35ab71f71c7	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	22f9eeaa-8aad-44f6-8258-e41edb60f876	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	1a190488-3444-43b0-b9c8-45c1eb371aad	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	c10cc127-8756-4ddc-9f46-1e003ef271dc	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	d9841f2d-d182-4888-9a3c-68e1afb3e19c	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ef58f422-682e-6896-e053-2a95a90a1f2d	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	1bcddbe1-c453-43ec-a822-9e993b885a5f	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091490 application number: ANDA091490

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	1bcddbe1-c453-43ec-a822-9e993b885a5f	105
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	1bcddbe1-c453-43ec-a822-9e993b885a5f	105
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	7503ef9d-0fad-421f-951a-f35ab71f71c7	103
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	7503ef9d-0fad-421f-951a-f35ab71f71c7	103
1049683	oxyCODONE HCl 10 MG Oral Tablet	PSN	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049686	oxyCODONE HCl 20 MG Oral Tablet	PSN	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049683	oxycodone hydrochloride 10 MG Oral Tablet	SCD	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049686	oxycodone hydrochloride 20 MG Oral Tablet	SCD	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	a5162476-1217-41c0-bc7e-0a0f123f069f	26
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	f45f04ea-5bb9-e8b6-e053-2a95a90a4d84	2
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	ef58f422-682e-6896-e053-2a95a90a1f2d	2
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	ef58f422-682e-6896-e053-2a95a90a1f2d	2
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	f45f04ea-5bb9-e8b6-e053-2a95a90a4d84	2
1049683	oxyCODONE HCl 10 MG Oral Tablet	PSN	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049686	oxyCODONE HCl 20 MG Oral Tablet	PSN	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049683	oxycodone hydrochloride 10 MG Oral Tablet	SCD	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049686	oxycodone hydrochloride 20 MG Oral Tablet	SCD	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	c10cc127-8756-4ddc-9f46-1e003ef271dc	1
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	c10cc127-8756-4ddc-9f46-1e003ef271dc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-001-01	42858000101	100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01)	100 tablet	2014-09-08	0000-00-00	No	No	Current
42858-001-10	42858000110	10 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2014-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	Rhodes Pharmaceuticals LLC \| Knoa Pharmaceuticals LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	26
Oxycodone Hydrochloride	Bryant Ranch Prepack	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	103
Oxycodone Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	1
Oxycodone Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-09-06	HUMAN PRESCRIPTION DRUG LABEL	2
Oxycodone Hydrochloride	Bryant Ranch Prepack	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	105
Oxycodone Hydrochloride	Redpharm Drug, Inc	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2