Lorazepam

Product NDC: 67046-0230
11-digit product format: 670460230
Labeler code: 67046
Product ID: 67046-0230_54d72f7d-9934-636b-e063-6294a90a764f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA072927
Marketing category: ANDA
Marketing start: 2026-06-22
Substance: LORAZEPAM
Active strength: 1 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
A072927-001	LORAZEPAM	LORAZEPAM	1MG	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
A072927-001	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	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	LORAZEPAM	1MG	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	A072927-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072927-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	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	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O26FZP769L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197901	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
54d72943-f8d1-5a78-e063-6294a90a059b	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	6c5356b1-c199-49ad-bb00-fd67c6691f74	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Coupler LLC	54d72943-f8d1-5a78-e063-6294a90a059b	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927 ndc (product): 67046-0230
Lorazepam	LORAZEPAM	Redpharm Drug	52614947-c96c-3361-e063-6394a90ae172	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7afd9a59-3463-4eda-8cf3-ef90be05de3d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
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): 072927 application number: ANDA072927
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): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927

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	Sample	Exclude flag	Status
67046-0230-3	67046023003	30 TABLET in 1 BLISTER PACK (67046-0230-3)	30 tablet	2026-06-22	No	No	Current