Lorazepam

Product NDC: 70518-3806
Requested package NDC: 70518-3806-3
11-digit product format: 705183806
Labeler code: 70518
Product ID: 70518-3806_5ca0c3de-5308-9f1f-e063-6294a90a8bf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA072926
Marketing category: ANDA
Marketing start: 2023-07-25
Substance: LORAZEPAM
Active strength: .5 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A072926-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB		1991-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072926-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072926-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A072926-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072926-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072926-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072926-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072926-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072926-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072926-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072926-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072926-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072926-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072926-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072926-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072926-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072926-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072926-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072926-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072926-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072926-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072926-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072926-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072926-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072926-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072926-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072926-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072926-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072926-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072926-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072926-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072926-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072926-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072926-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072926-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072926-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072926-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072926-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072926-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072926-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072926-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072926-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072926-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lorazepam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	.5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a759f740-8682-4896-9194-8b6c103c9aee	Product name	3	20250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1	Product name	1	20220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285	Product name	2	20180320
ac8efea8-f412-295f-00ce-b095e5cbc115	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3806-0	Lorazepam	30 in 1 BLISTER PACK	TABLET	30	6
70518-3806-1	Lorazepam	100 in 1 BOX	TABLET	100	6
70518-3806-2	Lorazepam	1 in 1 POUCH	TABLET	1	6
70518-3806-3	Lorazepam	100 in 1 BOX	TABLET	100	6
70518-3806-4	Lorazepam	1 in 1 POUCH	TABLET	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3806	LORAZEPAM TABLET [REMEDYREPACK INC.]	3	Current NDC, 5 package rows	20250129_ac1f88c2-2cf2-47de-a612-946cd4503090.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	5519bba8-9eb7-a3e0-e063-6294a90afd94	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	Redpharm Drug	5407f327-3a22-8c15-e063-6294a90a3169	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	ac1f88c2-2cf2-47de-a612-946cd4503090	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926 ndc (package): 70518-3806-3 ndc (product): 70518-3806 ndc11 (package): 70518380603
Lorazepam	LORAZEPAM	Coupler LLC	51119efa-c1a3-71f0-e063-6394a90a9e2a	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7999b9c3-6185-4e4e-a4c3-d5d33d6c31d6	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	3c20c89f-c8c3-43b3-837e-da413f449795	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	Golden State Medical Supply, Inc.	32fb5628-bf80-0135-e063-6294a90aa3ab	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926
Lorazepam	LORAZEPAM	Proficient Rx LP	a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072926 application number: ANDA072926

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197900	LORazepam 0.5 MG Oral Tablet	PSN	ac1f88c2-2cf2-47de-a612-946cd4503090	6
197900	lorazepam 0.5 MG Oral Tablet	SCD	ac1f88c2-2cf2-47de-a612-946cd4503090	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3806-3	70518380603	100 POUCH in 1 BOX (70518-3806-3) / 1 TABLET in 1 POUCH (70518-3806-4)	100 pouch	2025-12-23	No	No	Current