Oxycodone Hydchloride

Product NDC: 49999-899
Requested package NDC: 49999-899-21
11-digit product format: 499990899
Labeler code: 49999
Product ID: 49999-899_13014be8-5073-42af-b13d-af29c8b906ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydchloride
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA091393
Marketing category: ANDA
Marketing start: 2011-12-20
Marketing end: 2027-06-30
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

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	49999-899	49999-899-21	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A091393-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31
A091393-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31
A091393-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31
A091393-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31
A091393-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091393-001	AB
A091393-002	AB
A091393-003	AB
A091393-004	AB
A091393-005	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 · 210 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
2026-08-18 06:07:40	2026-07	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091393-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091393-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091393-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone Hydchloride

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
b9847cc7-67a2-408d-93cf-f9cf420346dd	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	SPL version
49999-899-00	Oxycodone Hydchloride	100 in 1 BOTTLE	TABLET	100	3413
49999-899-15	Oxycodone Hydchloride	15 in 1 BOTTLE	TABLET	15	3413
49999-899-21	Oxycodone Hydchloride	21 in 1 BOTTLE	TABLET	21	3413
49999-899-30	Oxycodone Hydchloride	30 in 1 BOTTLE	TABLET	30	3413
49999-899-40	Oxycodone Hydchloride	40 in 1 BOTTLE	TABLET	40	3413
49999-899-60	Oxycodone Hydchloride	60 in 1 BOTTLE	TABLET	60	3413
49999-899-90	Oxycodone Hydchloride	90 in 1 BOTTLE	TABLET	90	3413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-899-15	EA - Each	49999-899	ee1de391-eed1-4fef-b768-577ac33e722e	1	2019-07-02
49999-899-21	EA - Each	49999-899	e395d211-b6dc-43cd-b91f-03d09c89a3c4	1	2019-07-02
49999-899-30	EA - Each	49999-899	124c2c8f-a71c-4a48-bd12-a12436c47911	1	2012-07-24
49999-899-40	EA - Each	49999-899	c8f73651-b3a0-44a5-be7d-6a6e7d804ef4	1	2012-07-24
49999-899-60	EA - Each	49999-899	807b0724-4daa-49f6-8a17-9cf7c73cdd02	1	2012-07-24
49999-899-90	EA - Each	49999-899	a30dc3cf-6e4d-4f77-a0e1-ebce5823b173	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3405
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49999-899	OXYCODONE HYDCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]	3413	Current NDC, Legacy NDC, 7 package rows	20241222_b9847cc7-67a2-408d-93cf-f9cf420346dd.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	St. Mary's Medical Park Pharmacy	3ccf459a-fb11-e137-e063-6394a90a5a80	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	685d9709-028e-4422-bf0c-fde577b718a2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-TECH,INC	e73897d6-b920-4300-a564-5dbc9c8e9fe9	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	424fdfc7-1c92-2e62-e063-6394a90a136b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	American Health Packaging	aa7ac2bf-d9ed-445d-b394-4d3fe39780ca	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3cd01fb7-b59c-fc5d-e063-6394a90a21d2	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	a8206207-ad09-83df-e053-2995a90a78b7	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	31189587-a2dc-e0a1-e063-6394a90ae17d	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone Hydchloride	OXYCODONE HYDCHLORIDE	Quality Care Products LLC	b9847cc7-67a2-408d-93cf-f9cf420346dd	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393 ndc (package): 49999-899-21 ndc (product): 49999-899 ndc11 (package): 49999089921
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Quality Care Products LLC	4cadb809-157d-49cc-97b4-3276594f19d2	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone Hydchloride	OXYCODONE HYDCHLORIDE	Quality Care Products LLC	28156b13-0ba9-4dc4-be24-9c3070a7e1cc	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	17f7946d-e889-b736-e063-6394a90a42e0	2024-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393

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	b9847cc7-67a2-408d-93cf-f9cf420346dd	3413
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	b9847cc7-67a2-408d-93cf-f9cf420346dd	3413

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-899-21	49999089921	21 TABLET in 1 BOTTLE (49999-899-21)	21 tablet	2019-06-14	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYCODONE HYDROCHLORIDE Tablets USP	Quality Care Products LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	3413