Lorazepam

Product NDC: 60760-948
11-digit product format: 607600948
Labeler code: 60760
Product ID: 60760-948_569e8a5a-ddf6-ebbc-e063-6294a90ab7a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA218597
Marketing category: ANDA
Marketing start: 2026-07-07
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218597-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24
A218597-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24
A218597-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218597-001	AB
A218597-002	AB
A218597-003	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
2026-09-14 22:38:34	2026-08	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2025-07-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2025-07-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2025-07-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218597-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218597-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218597-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218597-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218597-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218597-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218597-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218597-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218597-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218597-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218597-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218597-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218597-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218597-003	AB	1	`a50c72e98297…`

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
569e8a5a-ddf7-ebbc-e063-6294a90ab7a4	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	56093df3-10f6-e747-e063-6294a90a6564	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218597 application number: ANDA218597
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	569e8a5a-ddf7-ebbc-e063-6294a90ab7a4	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218597 application number: ANDA218597 ndc (product): 60760-948
Lorazepam	LORAZEPAM	Rising Pharma Holdings, Inc.	386255e2-65aa-48ce-9eb1-246f1493cc14	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218597 application number: ANDA218597

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
60760-948-02	60760094802	2 TABLET in 1 BOTTLE, PLASTIC (60760-948-02)	2 tablet	2026-07-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP	St. Mary's Medical Park Pharmacy	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	1