Lorazepam

Product NDC: 65162-017
11-digit product format: 651620017
Labeler code: 65162
Product ID: 65162-017_afd7fdfa-e858-4385-8750-1dd07091b71a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA078826
Marketing category: ANDA
Marketing start: 2010-06-23
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65162-017		D	Discontinued by firm	2026-10-15
excluded package	package	65162-017	65162-017-10	D	Discontinued by firm	2026-10-15
excluded package	package	65162-017	65162-017-11	D	Discontinued by firm	2026-10-15
excluded package	package	65162-017	65162-017-50	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078826-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23
A078826-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23
A078826-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078826-002	LORAZEPAM	1MG	TABLET / ORAL	2010-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078826-003	LORAZEPAM	2MG	TABLET / ORAL	2010-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078826-001	LORAZEPAM	0.5MG	TABLET / ORAL	2010-06-23	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A078826-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078826-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078826-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078826-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078826-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078826-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078826-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078826-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078826-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078826-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078826-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078826-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078826-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078826-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078826-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078826-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078826-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-017-10	EA - Each	65162-017	c7959a38-d716-4171-9c47-25eefb1aa8ec	1	2012-07-24
65162-017-50	EA - Each	65162-017	b5619f11-88c4-4ca6-a4d7-247cb5c71a76	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-017	LORAZEPAM TABLET [AMNEAL PHARMACEUTICALS LLC]	16	Legacy NDC	20241030_4fae1607-69d7-47ce-9b78-7474af50036d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O26FZP769L	LORAZEPAM	846-49-1	LORAZEPAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-017-10	65162001710	100 TABLET in 1 BOTTLE (65162-017-10)	100 tablet	2010-06-23	0000-00-00	No	No	Current
65162-017-11	65162001711	1000 TABLET in 1 BOTTLE (65162-017-11)	1000 tablet	2010-06-23	0000-00-00	No	No	Current
65162-017-50	65162001750	500 TABLET in 1 BOTTLE (65162-017-50)	500 tablet	2010-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets USP, CIV Rx Only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2023-05-28	HUMAN PRESCRIPTION DRUG LABEL	16