OXYCODONE HYDROCHLORIDE

Product NDC: 55700-509
Requested package NDC: 55700-509-01
11-digit product format: 557000509
Labeler code: 55700
Product ID: 55700-509_622455fc-2653-4895-9d48-af093f9abafe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA091393
Marketing category: ANDA
Marketing start: 2013-10-18
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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	55700-509	55700-509-01	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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-509-01	EA - Each	55700-509	13e182a6-5384-4d12-bc44-7d7a68ba5dfc	1	2017-04-05
55700-509-30	EA - Each	55700-509	29853492-79ce-4fe0-b44d-d5862c2b9c70	1	2017-05-04

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-509-01	55700050901	120 TABLET in 1 BOTTLE (55700-509-01)	120 tablet	2017-03-03	0000-00-00	No	No	Current