Lorazepam

Product NDC: 0615-8003
11-digit product format: 006158003
Labeler code: 0615
Product ID: 0615-8003_8c995d4f-2a20-4210-bfff-08c9183db168
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA077754
Marketing category: ANDA
Marketing start: 2006-05-10
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-8003		D	Discontinued by firm		2026-08-03
excluded package	package	0615-8003	0615-8003-39	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-8003-39	2021-07-09	C162847	48780-1	9d75b9d0-f12d-f424-e053-dadaa90a57ce	LORAZEPAM TABLETS, USP CIV Rx only
0615-8003-39	2020-01-31	C162847	48780-1	9d75b9d0-f12d-f424-e053-dadaa90a57ce	LORAZEPAM TABLETS, USP CIV Rx only

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LORAZEPAM TABLETS, USP CIV Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2016-06-02	HUMAN PRESCRIPTION DRUG LABEL	1