Lorazepam

Product NDC: 51407-998
Requested package NDC: 51407-998-01
11-digit product format: 514070998
Labeler code: 51407
Product ID: 51407-998_32fb620b-e335-0718-e063-6294a90ac33c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA072928
Marketing category: ANDA
Marketing start: 1991-10-31
Substance: LORAZEPAM
Active strength: 2 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

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

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
A072928-001	LORAZEPAM	LORAZEPAM	2MG	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
A072928-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072928-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	551a1b7f-d342-2c53-e063-6394a90a9a2a	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	ed37d304-04cf-43ec-a58d-d72002ff889b	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
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): 072928 application number: ANDA072928
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): 072928 application number: ANDA072928 ndc (package): 51407-998-01 ndc (product): 51407-998 ndc11 (package): 51407099801
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	2 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197900	Internal RxNorm lookup
197901	Internal RxNorm lookup
197902	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
32fb5628-bf80-0135-e063-6294a90aa3ab	Available on FDA.report

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	Strength	SPL version
51407-998-01	Lorazepam	100 in 1 BOTTLE, PLASTIC	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-998-01	EA - Each	51407-998	eb9e7493-b028-4b8e-b3bc-2f829be0c52f	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-998	LORAZEPAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1	Current NDC, 1 package rows	20250418_32fb5628-bf80-0135-e063-6294a90aa3ab.zip

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	32fb5628-bf80-0135-e063-6294a90aa3ab	1
197901	LORazepam 1 MG Oral Tablet	PSN	32fb5628-bf80-0135-e063-6294a90aa3ab	1
197902	LORazepam 2 MG Oral Tablet	PSN	32fb5628-bf80-0135-e063-6294a90aa3ab	1
197900	lorazepam 0.5 MG Oral Tablet	SCD	32fb5628-bf80-0135-e063-6294a90aa3ab	1
197901	lorazepam 1 MG Oral Tablet	SCD	32fb5628-bf80-0135-e063-6294a90aa3ab	1
197902	lorazepam 2 MG Oral Tablet	SCD	32fb5628-bf80-0135-e063-6294a90aa3ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51407-998-01	51407099801	100 TABLET in 1 BOTTLE, PLASTIC (51407-998-01)	100 tablet	2025-03-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP C-IV	Golden State Medical Supply, Inc.	2025-04-17	HUMAN PRESCRIPTION DRUG LABEL	1