OXYCODONE HYDROCHLORIDE

Product NDC: 61919-444
Requested package NDC: 61919-444-30
11-digit product format: 619190444
Labeler code: 61919
Product ID: 61919-444_94e507c3-429b-a215-e053-2995a90a0d52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA202662
Marketing category: ANDA
Marketing start: 2018-03-15
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 10 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#

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-444	61919-444-30	D	Discontinued by firm		2026-08-17
excluded package	package	61919-444	61919-444-30	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A202662-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22
A202662-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22
A202662-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22
A202662-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22
A202662-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202662-001	AB
A202662-002	AB
A202662-003	AB
A202662-004	AB
A202662-005	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`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	A202662-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202662-005	AB	1	`2680178bc6a6…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-444-30	2023-01-30	C162847	48780-1	f386c64a-2401-0266-e053-dadaa90a7c1a	OXYCODONE HYDROCHLORIDE
61919-444-60	2023-01-30	C162847	48780-1	f386c64a-2401-0266-e053-dadaa90a7c1a	OXYCODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-444-30	OXYCODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		4
61919-444-60	OXYCODONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-444-30	EA - Each	61919-444	26a12ca2-6fbe-4ed1-9a5c-501c06374bb9	1	2018-04-19
61919-444-60	EA - Each	61919-444	1638ed36-7b0d-4ae5-9ee6-8333577aeb32	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-444	OXYCODONE HYDROCHLORIDE TABLET [DIRECT RX]	4	Legacy NDC, 2 package rows	20191015_67388b5c-6371-7826-e053-2a91aa0a9231.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Epic Pharma, LLC	cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0	2022-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202662 application number: ANDA202662

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
1049683	oxyCODONE HCl 10 MG Oral Tablet	PSN	67388b5c-6371-7826-e053-2a91aa0a9231	4
1049683	oxycodone hydrochloride 10 MG Oral Tablet	SCD	67388b5c-6371-7826-e053-2a91aa0a9231	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-444-30	61919044430	30 TABLET in 1 BOTTLE (61919-444-30)	30 tablet	2018-03-15	0000-00-00	No	No	Current