OXYCODONE HYDROCHLORIDE

Product NDC: 55700-175
Requested package NDC: 55700-175-90
11-digit product format: 557000175
Labeler code: 55700
Product ID: 55700-175_1359d9b6-085e-4c79-b421-d4339ed08b5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA091393
Marketing category: ANDA
Marketing start: 2013-10-18
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	55700-175	55700-175-90	D	Discontinued by firm		2026-07-31

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	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.

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
2026-08-01 22:54:32	2026-06	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A091393-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091393-005	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 55700-175-90 ndc (product): 55700-175 ndc11 (package): 55700017590
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

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
55700-175-01	OXYCODONE HYDROCHLORIDE	120 in 1 BOTTLE	TABLET	120	9
55700-175-30	OXYCODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	9
55700-175-60	OXYCODONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	9
55700-175-90	OXYCODONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-175-01	EA - Each	55700-175	a0afc2ce-c29f-4d5c-877d-c0d298421fb3	1	2015-12-02
55700-175-30	EA - Each	55700-175	1b51fd09-3076-48b2-8b00-0df06de17af9	1	2015-12-02
55700-175-60	EA - Each	55700-175	5887feb2-d3de-46ed-a392-4c4e4ae2ff2e	1	2015-12-02
55700-175-90	EA - Each	55700-175	02c592d6-f544-4d92-b935-ea5617c55bdb	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE 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
55700-175	OXYCODONE HYDROCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]	9	Legacy NDC, 4 package rows	20241222_4cadb809-157d-49cc-97b4-3276594f19d2.zip

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
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	4cadb809-157d-49cc-97b4-3276594f19d2	9
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	4cadb809-157d-49cc-97b4-3276594f19d2	9
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	4cadb809-157d-49cc-97b4-3276594f19d2	9
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	4cadb809-157d-49cc-97b4-3276594f19d2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-175-90	55700017590	90 TABLET in 1 BOTTLE (55700-175-90)	90 tablet	2013-10-18	0000-00-00	No	No	Current