Lorazepam

Product NDC: 0603-4246
11-digit product format: 006034246
Labeler code: 0603
Product ID: 0603-4246_bf42e19a-d10c-42dc-a102-7b3eab2f330e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Qualitest Pharmaceuticals
Application: ANDA077754
Marketing category: ANDA
Marketing start: 2006-05-10
Marketing end: 2020-05-30
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0603-4246		D	Discontinued by firm	2026-08-03
excluded package	package	0603-4246	0603-4246-21	D	Discontinued by firm	2026-08-03
excluded package	package	0603-4246	0603-4246-28	D	Discontinued by firm	2026-08-03
excluded package	package	0603-4246	0603-4246-32	D	Discontinued by firm	2026-08-03

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

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
A077754-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10
A077754-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10
A077754-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077754-001	AB
A077754-002	AB
A077754-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077754-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077754-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077754-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-05-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077754-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077754-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077754-003	AB	1	`a50c72e98297…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-4246-21	EA - Each	0603-4246	25fa03c3-1c00-4e22-8295-29fbd6f1d177	1	2013-12-02
0603-4246-28	EA - Each	0603-4246	f628ad19-cf89-402f-a225-43db9fbdd9d7	1	2013-12-02
0603-4246-32	EA - Each	0603-4246	c78bf0a4-efc0-48af-bf4d-d7774a71ae6b	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]	6

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	4e409ad8-0090-1fe1-e054-00144ff8d46c	3
197900	lorazepam 0.5 MG Oral Tablet	SCD	4e409ad8-0090-1fe1-e054-00144ff8d46c	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
LORAZEPAM TABLETS, USP CIV Rx only	Qualitest Pharmaceuticals	2018-12-03	HUMAN PRESCRIPTION DRUG LABEL	8
LORAZEPAM TABLETS, USP CIV Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2016-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
LORAZEPAM TABLETS, USP CIV Rx only	Avera McKennan Hospital	2016-01-05	HUMAN PRESCRIPTION DRUG LABEL	1