Lorazepam

Product NDC: 12634-867
11-digit product format: 126340867
Labeler code: 12634
Product ID: 12634-867_5f71530d-599c-4eb7-bbf4-716dfdfd09ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca, Inc
Application: ANDA076045
Marketing category: ANDA
Marketing start: 2001-12-11
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: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	12634-867		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-867	12634-867-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-867	12634-867-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-867	12634-867-91	I	Inactivated by FDA	2026-08-17

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-867-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-867-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-867-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-867-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-867-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-867-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-867-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-867-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-867-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-867-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-867-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-867-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-867-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-867-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-867-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-867-91	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-867-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-867-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-867-91	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-867-71	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-867-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12634-867-91	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12634-867-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12634-867-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	12634-867-91	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	12634-867-71	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	12634-867-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	12634-867-91	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	12634-867-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	12634-867-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	12634-867-91	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	12634-867-71	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	12634-867-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	12634-867-91	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	12634-867-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	12634-867-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	12634-867-91	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	12634-867-71	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	12634-867-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	12634-867-91	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	12634-867-71	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	12634-867-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12634-867-91	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12634-867-71	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12634-867-00	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076045-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29
A076045-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29
A076045-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076045-001	AB
A076045-002	AB
A076045-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076045-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076045-001	AB	1	`1e350fbaab3a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
12634-867-00	2020-01-31	C162847	48780-1	9d75b9d0-9202-f424-e053-dadaa90a57ce	Lorazepam Tablets, USP, CIV Rx Only
12634-867-71	2020-01-31	C162847	48780-1	9d75b9d0-9202-f424-e053-dadaa90a57ce	Lorazepam Tablets, USP, CIV Rx Only
12634-867-91	2020-01-31	C162847	48780-1	9d75b9d0-9202-f424-e053-dadaa90a57ce	Lorazepam Tablets, USP, CIV Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-867-00	Lorazepam	10 in 1 BOTTLE	TABLET	10	1
12634-867-71	Lorazepam	30 in 1 BOTTLE	TABLET	30	1
12634-867-91	Lorazepam	1 in 1 BLISTER PACK	TABLET	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [APOTHECA, INC]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [APOTHECA, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [APOTHECA, INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORAZEPAM TABLET [APOTHECA, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [APOTHECA, INC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [APOTHECA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-867	LORAZEPAM TABLET [APOTHECA, INC]	1	Legacy NDC, 3 package rows	20141023_46238e9c-cf5b-4dc0-b8b4-d0203913f1dd.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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	1f79a5a1-0c40-45cf-8994-51f5ba3a5938	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	86630bdd-13ad-4ab5-9e94-fcf2ea2113e1	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	08a30230-fc95-9025-e063-6394a90ae21b	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	17919c82-87f2-5030-e063-6294a90ac91a	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1791d5c9-9004-5c4b-e063-6294a90adf3d	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	29f63525-2839-946c-e063-6294a90aebb1	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	ebdf72f7-7462-4b83-81b4-c7988860c728	2024-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1bcf608a-11c1-ec7d-e063-6394a90ab710	2024-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	0ce02d7d-d855-c73f-e063-6294a90abe93	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	SUN PHARMACEUTICAL INDUSTRIES INC	0c1caa9c-9ef1-459c-86c3-adb939130a9f	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045

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
197901	LORazepam 1 MG Oral Tablet	PSN	46238e9c-cf5b-4dc0-b8b4-d0203913f1dd	1
197901	lorazepam 1 MG Oral Tablet	SCD	46238e9c-cf5b-4dc0-b8b4-d0203913f1dd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-867-00	12634086700	10 in 1 BOTTLE	Historical
12634-867-71	12634086771	30 in 1 BOTTLE	Historical
12634-867-91	12634086791	1 in 1 BLISTER PACK	Historical