Oxazepam

Product NDC: 67544-117
11-digit product format: 675440117
Labeler code: 67544
Product ID: 67544-117_166ba137-98a4-4072-90e1-ab7b6248a351
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxazepam
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA072251
Marketing category: ANDA
Marketing start: 2007-01-02
Marketing end: 0000-00-00
Substance: OXAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-117		I	Inactivated by FDA	2026-08-03
excluded package	package	67544-117	67544-117-30	I	Inactivated by FDA	2026-08-03
excluded package	package	67544-117	67544-117-53	I	Inactivated by FDA	2026-08-03
excluded package	package	67544-117	67544-117-60	I	Inactivated by FDA	2026-08-03
excluded package	package	67544-117	67544-117-70	I	Inactivated by FDA	2026-08-03

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 2 · 75 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	67544-117-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-117-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-117-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-117-30	`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	67544-117-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-117-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-117-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-117-30	`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	67544-117-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-117-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-117-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-117-30	`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	67544-117-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-117-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-117-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-117-30	`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	67544-117-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-117-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-117-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-117-30	`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	67544-117-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-117-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-117-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-117-30	`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	67544-117-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-117-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-117-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-117-30	`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	67544-117-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-117-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-117-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-117-30	`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	67544-117-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-117-70	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-117-53	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-117-30	`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	67544-117-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-117-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-117-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-117-30	`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	67544-117-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-117-70	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-117-53	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-117-30	`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	67544-117-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-117-70	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-117-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-117-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0bf93631-d4c9-1bc6-b689-709626127556	Product name	2	20251210

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-117-30	OXAZEPAM CAPSULES, USP
67544-117-53	OXAZEPAM CAPSULES, USP
67544-117-60	OXAZEPAM CAPSULES, USP
67544-117-70	OXAZEPAM CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-117-30	Oxazepam	30 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	30	3
67544-117-53	Oxazepam	60 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	60	3
67544-117-60	Oxazepam	90 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	90	3
67544-117-70	Oxazepam	120 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	120	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-117-30	EA - Each	67544-117	7e62f887-9679-491b-8187-c762f94064b1	1	2014-05-02
67544-117-53	EA - Each	67544-117	d91900d4-30a1-4dc3-9187-8c8751399c23	1	2014-05-02
67544-117-60	EA - Each	67544-117	ec0a3698-0758-4a0d-bb0b-0780fa329c0c	1	2014-05-02
67544-117-70	EA - Each	67544-117	c421d610-6778-4d19-8be1-40e114b575b6	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXAZEPAM	ACTIVE INGREDIENT	6GOW6DWN2A	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
OXAZEPAM	ACTIVE MOIETY	6GOW6DWN2A	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-117	OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 4 package rows	20191224_3bccbfa9-fdcf-44c3-86f5-028ca92223ca.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GOW6DWN2A	OXAZEPAM	604-75-1	OXAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198057	oxazepam 10 MG Oral Capsule	PSN	3bccbfa9-fdcf-44c3-86f5-028ca92223ca	3
312134	oxazepam 15 MG Oral Capsule	PSN	3bccbfa9-fdcf-44c3-86f5-028ca92223ca	3
198057	oxazepam 10 MG Oral Capsule	SCD	3bccbfa9-fdcf-44c3-86f5-028ca92223ca	3
312134	oxazepam 15 MG Oral Capsule	SCD	3bccbfa9-fdcf-44c3-86f5-028ca92223ca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-117-30	67544011730	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-30)	2007-02-01	0000-00-00	No	No	Current
67544-117-53	67544011753	60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-53)	2007-01-18	0000-00-00	No	No	Current
67544-117-60	67544011760	90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-60)	2007-01-22	0000-00-00	No	No	Current
67544-117-70	67544011770	120 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-70)	2007-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXAZEPAM CAPSULES, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-20	HUMAN PRESCRIPTION DRUG LABEL	3