Oxycodone Hydrochloride

Product NDC: 68462-204
11-digit product format: 684620204
Labeler code: 68462
Product ID: 68462-204_5a288bc7-4ba4-45a9-ae81-9c3f675524be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Glenmark Pharmaceuticals, Inc
Application: NDA200534
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-12-15
Marketing end: 0000-00-00
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: 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 product	product	68462-204		I	Inactivated by FDA		2026-08-17
excluded package	package	68462-204	68462-204-01	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-204-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-204-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-204-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-204-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-204-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-204-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-204-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-204-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-204-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-204-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-204-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-204-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68462-204-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68462-204-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68462-204-01	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200534-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200534-001	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 2 · 42 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	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N200534-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200534-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	M-14	2024-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	M-14	2024-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	M-14	2024-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	M-14	2024-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	M-14	2024-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	M-14	2024-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	M-14	2024-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	M-14	2024-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	M-14	2024-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	M-14	2024-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	M-14	2024-07-21	`1c564ffb4f44…`

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
68462-204-01	2024-01-30	C162847	48780-1	1030e365-133c-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-204-01	Oxycodone Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-204-01	EA - Each	68462-204	3147c7dc-c342-4538-bd49-e101ae662797	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
Oxycodone Hydrochloride	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
Oxycodone	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXYCODONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-204	OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK PHARMACEUTICALS, INC]	5	Legacy NDC, 1 package rows	20181218_566ef74d-5c0b-49bf-9619-e757d16431ef.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
1049696	oxyCODONE HCl 5 MG Oral Capsule	PSN	566ef74d-5c0b-49bf-9619-e757d16431ef	5
1049696	oxycodone hydrochloride 5 MG Oral Capsule	SCD	566ef74d-5c0b-49bf-9619-e757d16431ef	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-204-01	68462020401	100 CAPSULE in 1 BOTTLE (68462-204-01)	100 capsule	2010-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	Glenmark Pharmaceuticals, Inc \| Genus Lifesciences Inc	2018-12-12	HUMAN PRESCRIPTION DRUG LABEL	5
Oxycodone Hydrochloride	Bryant Ranch Prepack	2013-01-18	HUMAN PRESCRIPTION DRUG LABEL	1000
oxycodone hydrochloride 5mg Capsule	bryant ranch prepack	2010-03-08	HUMAN PRESCRIPTION DRUG LABEL	2