Quazepam

Product NDC: 71993-265
Requested package NDC: 71993-265-10
11-digit product format: 719930265
Labeler code: 71993
Product ID: 71993-265_41da82ab-fab6-7eba-e063-6394a90a037e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quazepam
Dosage form: TABLET
Route: ORAL
Labeler: Atland Pharmaceuticals, LLC
Application: NDA018708
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-03-20
Substance: QUAZEPAM
Active strength: 15 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71993-265	71993-265-10	D	Discontinued by firm		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 1 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018708-001	DORAL	QUAZEPAM	15MG	TABLET / ORAL		RLD, RS	1985-12-27
N018708-003	DORAL	QUAZEPAM	7.5MG	TABLET / ORAL			1987-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N018708-001	7608616	2028-06-03	U-1012
N018708-003	7608616	2028-06-03	U-1012

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018708-001	DORAL	15MG	TABLET / ORAL	RLD, RS	1985-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018708-003	DORAL	7.5MG	TABLET / ORAL		1987-02-26	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018708-001	7608616	2028-06-03	U-1012	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018708-003	7608616	2028-06-03	U-1012	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018708-001	7608616	2028-06-03	U-1012	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018708-003	7608616	2028-06-03	U-1012	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018708-001	7608616	2028-06-03	U-1012	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018708-003	7608616	2028-06-03	U-1012	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018708-001	7608616	2028-06-03	U-1012	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018708-003	7608616	2028-06-03	U-1012	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018708-001	7608616	2028-06-03	U-1012	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018708-003	7608616	2028-06-03	U-1012	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018708-001	7608616	2028-06-03	U-1012	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018708-003	7608616	2028-06-03	U-1012	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018708-001	7608616	2028-06-03	U-1012	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018708-003	7608616	2028-06-03	U-1012	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018708-001	7608616	2028-06-03	U-1012	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018708-003	7608616	2028-06-03	U-1012	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018708-001	7608616	2028-06-03	U-1012	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018708-003	7608616	2028-06-03	U-1012	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018708-001	7608616	2028-06-03	U-1012	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018708-003	7608616	2028-06-03	U-1012	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018708-001	7608616	2028-06-03	U-1012	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018708-003	7608616	2028-06-03	U-1012	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018708-001	7608616	2028-06-03	U-1012	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018708-003	7608616	2028-06-03	U-1012	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018708-001	7608616	2028-06-03	U-1012	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018708-003	7608616	2028-06-03	U-1012	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018708-001	7608616	2028-06-03	U-1012	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018708-003	7608616	2028-06-03	U-1012	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018708-001	7608616	2028-06-03	U-1012	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018708-003	7608616	2028-06-03	U-1012	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018708-001	7608616	2028-06-03	U-1012	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018708-003	7608616	2028-06-03	U-1012	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018708-001	7608616	2028-06-03	U-1012	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018708-003	7608616	2028-06-03	U-1012	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018708-001	7608616	2028-06-03	U-1012	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018708-003	7608616	2028-06-03	U-1012	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018708-001	7608616	2028-06-03	U-1012	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018708-003	7608616	2028-06-03	U-1012	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018708-001	7608616	2028-06-03	U-1012	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018708-003	7608616	2028-06-03	U-1012	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Quazepam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUAZEPAM	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JF8V0828ZI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198183	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f7d63f3f-5303-48ab-bce2-35fd62c45799	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5365ec8f-be1e-1313-9069-11394f07d211	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71993-265-10	Quazepam	100 in 1 BOTTLE	TABLET	100		17
71993-265-30	Quazepam	30 in 1 BOTTLE	TABLET	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71993-265-10	EA - Each	71993-265	2a19b1a0-b82f-4c29-be3a-4d9535d7637a	1	2018-05-09
71993-265-30	EA - Each	71993-265	5c3553b6-6db3-4186-9984-23946fb6ae8d	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71993-265	QUAZEPAM TABLET [ATLAND PHARMACEUTICALS, LLC]	15	Current NDC, Legacy NDC, 2 package rows	20241012_f7d63f3f-5303-48ab-bce2-35fd62c45799.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
Quazepam	QUAZEPAM	Atland Pharmaceuticals, LLC	f7d63f3f-5303-48ab-bce2-35fd62c45799	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018708 application number: NDA018708 ndc (package): 71993-265-10 ndc (product): 71993-265 ndc11 (package): 71993026510

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JF8V0828ZI	QUAZEPAM	36735-22-5	QUAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198183	quazepam 15 MG Oral Tablet	PSN	f7d63f3f-5303-48ab-bce2-35fd62c45799	17
198183	quazepam 15 MG Oral Tablet	SCD	f7d63f3f-5303-48ab-bce2-35fd62c45799	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71993-265-10	71993026510	100 TABLET in 1 BOTTLE (71993-265-10)	100 tablet	2018-03-20	0000-00-00	No	No	Current