Lorazepam

Product NDC: 71335-0329
Requested package NDC: 71335-0329-7
11-digit product format: 713350329
Labeler code: 71335
Product ID: 71335-0329_1577a3f6-8289-4621-a0e5-9d69bc6218d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078203
Marketing category: ANDA
Marketing start: 2023-05-16
Substance: LORAZEPAM
Active strength: .5 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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0329	71335-0329-7	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0329	71335-0329-7	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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

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	TE codes	Approval date
A078203-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30
A078203-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30
A078203-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078203-001	AB
A078203-002	AB
A078203-003	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 4 · 129 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	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078203-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078203-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-001	AB	1	`301d65b070ca…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	.5 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
197900	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
aac672f9-0ba7-4852-b8a7-caac9e4b1e77	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-0329-1	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-2	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-3	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-4	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-5	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-6	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-7	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-8	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-9	2024-05-15	Lorazepam Tablets, USP CIV Rx only
71335-0329-1	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-2	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-3	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-4	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-5	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-6	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-7	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-8	2024-01-30	Lorazepam Tablets, USP CIV Rx only
71335-0329-9	2024-01-30	Lorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0329-1	Lorazepam	30 in 1 BOTTLE	TABLET	30	11
71335-0329-2	Lorazepam	10 in 1 BOTTLE	TABLET	10	11
71335-0329-3	Lorazepam	60 in 1 BOTTLE	TABLET	60	11
71335-0329-4	Lorazepam	90 in 1 BOTTLE	TABLET	90	11
71335-0329-5	Lorazepam	15 in 1 BOTTLE	TABLET	15	11
71335-0329-6	Lorazepam	100 in 1 BOTTLE	TABLET	100	11
71335-0329-7	Lorazepam	120 in 1 BOTTLE	TABLET	120	11
71335-0329-8	Lorazepam	2 in 1 BOTTLE	TABLET	2	11
71335-0329-9	Lorazepam	5 in 1 BOTTLE	TABLET	5	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0329-1	EA - Each	71335-0329	38a4d62c-689e-47b7-a3e5-53641cca1d6d	1	2018-02-20
71335-0329-2	EA - Each	71335-0329	1c7b1946-7757-4298-9c06-15e89dabf6f3	1	2018-02-20
71335-0329-3	EA - Each	71335-0329	edc95b78-ed4c-4197-ab91-fb459cce27cc	1	2018-02-20
71335-0329-4	EA - Each	71335-0329	35a4a9e0-0cc7-4a0e-9c03-157030c1ee9c	1	2018-02-20
71335-0329-5	EA - Each	71335-0329	4f90930d-99f2-4f2a-a22a-b316ca4e6e76	1	2018-02-20
71335-0329-6	EA - Each	71335-0329	50e35d7a-2628-4442-982a-8e5c7b420e6f	1	2018-02-20
71335-0329-7	EA - Each	71335-0329	3fce819a-057c-4014-b77b-19a2b402a107	1	2018-02-20
71335-0329-8	EA - Each	71335-0329	3098f120-4cf5-4d5b-902a-d9ed7b64422f	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0329	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	11	Current NDC, Legacy NDC, 9 package rows	20240517_aac672f9-0ba7-4852-b8a7-caac9e4b1e77.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	d6364be4-056b-4ebe-83bc-3fc85e8f488c	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	b707ecb2-644c-4323-ab0e-7bc5929cd560	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Coupler LLC	5114810c-025f-6113-e063-6294a90af538	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	1009c870-fd98-4e3b-81c8-4184036fb8c2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	A-S Medication Solutions	8361519b-be1a-4542-a782-d7cdfa153e86	2026-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	a0a33933-f697-4d3b-ba99-8a995a4b6c6b	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
LORAZEPAM	LORAZEPAM	DIRECT RX	4832f02d-289c-2fe6-e054-00144ff8d46c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	RedPharm Drug, Inc.	891b2c10-942f-0e4d-e053-2995a90af028	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	PharmPak, Inc.	b6e4d2c7-10c0-4d77-be7b-caa3d3b86997	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0681c8db-ff09-4258-a5e0-76a26b0ea0af	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dd6-3746-e054-00144ff8d46c	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	503834f9-fa2e-5e23-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	A-S Medication Solutions	be85b116-9f09-403a-8e0d-e77e344d3a9a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dc1-3746-e054-00144ff8d46c	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4ab77192-8fe9-2965-e054-00144ff88e88	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	50379c41-2676-590c-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (package): 71335-0329-7 ndc (product): 71335-0329 ndc11 (package): 71335032907
Lorazepam	LORAZEPAM	Proficient Rx LP	e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203

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	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	11
197900	lorazepam 0.5 MG Oral Tablet	SCD	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0329-7	71335032907	120 TABLET in 1 BOTTLE (71335-0329-7)	120 tablet	2024-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV Rx only	Bryant Ranch Prepack	2024-05-15	HUMAN PRESCRIPTION DRUG LABEL	11