Lorazepam

Product NDC
71610-148
11-digit product format
716100148
Labeler code
71610
Product ID
71610-148_da96ca18-9352-4685-8be9-71d88637b766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071141
Marketing category
ANDA
Marketing start
2007-01-04
Marketing end
2021-09-30
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#

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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-148DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-15DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-30DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-53DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-55DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-60DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-70DDiscontinued by firm2026-10-05
excluded packagepackage71610-14871610-148-80DDiscontinued by firm2026-10-05

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 · 96 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-148-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-148-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-148-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-148-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-148-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-148-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-70302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-148-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-148-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-148-70ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-148-15ed331223b511…672a5bd82f5f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071141-001LORAZEPAMLORAZEPAM2MGTABLET / ORALAB1987-04-21
A071141-002LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB1987-04-21
A071141-003LORAZEPAMLORAZEPAM1MGTABLET / ORALAB1987-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071141-001AB
A071141-002AB
A071141-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-2184e616aacf4f…
2026-09-14 22:38:342026-08A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-2184e616aacf4f…
2026-09-14 22:38:342026-08A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-2184e616aacf4f…
2026-08-18 06:07:402026-07A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071141-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A071141-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A071141-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A071141-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071141-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071141-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071141-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071141-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071141-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071141-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071141-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071141-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071141-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071141-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071141-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071141-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071141-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071141-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071141-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071141-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071141-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071141-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071141-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071141-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-148-15EA - Each71610-14840b8857d-6074-408a-a27a-c29cd24382e612018-12-13
71610-148-30EA - Each71610-1489de1d471-828d-490f-99de-daf45ed8f66f12018-12-13
71610-148-53EA - Each71610-1486d501ae1-67bd-4eba-9f4b-d42938dbb03e12018-12-13
71610-148-55EA - Each71610-1487c2e0143-2c48-46e6-8c21-09935009453a12018-12-13
71610-148-60EA - Each71610-14811d60070-4aa3-4ab4-8c3c-4b94551926a412018-12-13
71610-148-70EA - Each71610-1484cfd7c29-1006-4a39-9cbe-b3d0dcd8f15e12018-12-13
71610-148-80EA - Each71610-1486baa7e0a-b9d8-4325-b6c2-ddf48140432c12018-12-13