Lorazepam

Product NDC
71610-149
11-digit product format
716100149
Labeler code
71610
Product ID
71610-149_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
2007-01-08
Marketing end
2021-09-30
Substance
LORAZEPAM
Active strength
2 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-149DDiscontinued by firm2026-10-16
excluded packagepackage71610-14971610-149-30DDiscontinued by firm2026-10-16
excluded packagepackage71610-14971610-149-53DDiscontinued by firm2026-10-16
excluded packagepackage71610-14971610-149-60DDiscontinued by firm2026-10-16

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 1 · 48 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 packagepackage71610-149-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-149-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-149-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-149-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-149-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-149-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-149-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-149-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-149-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-149-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-149-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-149-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-149-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-149-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-149-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-149-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-149-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-149-53cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-149-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-149-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-149-53302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-149-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-149-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-149-53ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-149-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-149-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-149-530efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-149-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-149-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-149-53ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-149-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-149-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-149-53367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-149-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-149-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-149-53557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A071141-001LORAZEPAM2MGTABLET / ORALAB1987-04-21c2088c7a36db…
2026-10-15 13:18:302026-09A071141-002LORAZEPAM0.5MGTABLET / ORALAB1987-04-21c2088c7a36db…
2026-10-15 13:18:302026-09A071141-003LORAZEPAM1MGTABLET / ORALAB1987-04-21c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A071141-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071141-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A071141-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A071141-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071141-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A071141-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A071141-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071141-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A071141-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A071141-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071141-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071141-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071141-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071141-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A071141-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A071141-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071141-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A071141-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A071141-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071141-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071141-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071141-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071141-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071141-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071141-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071141-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071141-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071141-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071141-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071141-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071141-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071141-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A071141-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A071141-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071141-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A071141-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A071141-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071141-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071141-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071141-003AB13a93d1ddd44b…

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
71610-149-30EA - Each71610-14963701cfd-b86b-4349-b7de-cc5522b2ea8112018-11-06
71610-149-53EA - Each71610-1492e7b6bea-d08e-4d7f-8d4f-a493afced11512018-11-06
71610-149-60EA - Each71610-14913869847-d17a-4a13-b5e5-f37a53391f2912018-11-06