FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-199
11-digit product format
716100199
Labeler code
71610
Product ID
71610-199_adbae6b7-14fd-4ce0-a7eb-2154805a2a16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
Substance
LORAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203572-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2017-12-22
A203572-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2017-12-22
A203572-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203572-001AB
A203572-002AB
A203572-003AB

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 22:38:342026-08A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2284e616aacf4f…
2026-09-14 22:38:342026-08A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2284e616aacf4f…
2026-09-14 22:38:342026-08A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22301d65b070ca…

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 22:38:342026-08A203572-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203572-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203572-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203572-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203572-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203572-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203572-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-001AB1301d65b070ca…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O26FZP769LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197900Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4fa14be-cef1-4b4b-b099-abde92f15145Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a759f740-8682-4896-9194-8b6c103c9aeeProduct name320250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1Product name120220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285Product name220180320
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-199-10Lorazepam10 in 1 BOTTLETABLET102
71610-199-15Lorazepam15 in 1 BOTTLETABLET152
71610-199-20Lorazepam20 in 1 BOTTLETABLET202
71610-199-30Lorazepam30 in 1 BOTTLETABLET302
71610-199-45Lorazepam45 in 1 BOTTLETABLET452
71610-199-53Lorazepam60 in 1 BOTTLETABLET602
71610-199-55Lorazepam75 in 1 BOTTLETABLET752
71610-199-60Lorazepam90 in 1 BOTTLETABLET902
71610-199-70Lorazepam120 in 1 BOTTLETABLET1202
71610-199-75Lorazepam150 in 1 BOTTLETABLET1502
71610-199-80Lorazepam180 in 1 BOTTLETABLET1802
71610-199-92Lorazepam270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-199-10EA - Each71610-199a0efd14c-a000-49b0-b0c9-20e952c47ee812019-02-13
71610-199-15EA - Each71610-199eb131d7d-cd61-45af-b9f2-d9f9e9131c5d12019-02-13
71610-199-20EA - Each71610-1996c2c3e6e-1994-4a8c-9d68-b0d7c7e9256b12019-02-13
71610-199-30EA - Each71610-19958465786-0772-4c0f-98dd-e763cd03a9da12019-02-13
71610-199-45EA - Each71610-19990453b6b-b300-4bd9-91d3-9ece7b5b19ef12019-02-13
71610-199-53EA - Each71610-199b15dd8d6-7986-4288-808f-d4b091c7736712019-02-13
71610-199-55EA - Each71610-19925860744-0e7e-4ff3-bd64-8aee70b5731112019-02-13
71610-199-60EA - Each71610-1995193c0f5-5920-4bd3-977e-33426bba20b912019-02-13
71610-199-70EA - Each71610-19928ae183b-2dc3-4480-ad96-3a8b94045dad12019-02-13
71610-199-75EA - Each71610-199011829b8-b90e-4708-9f5b-b70502283f5312019-02-13
71610-199-80EA - Each71610-199ac17aa0b-656d-4e2a-8f2d-237958af1dce12019-02-13
71610-199-92EA - Each71610-1995a8d8012-782c-4896-84c1-8198b5fb0b2912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-199LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 12 package rows20190109_a4fa14be-cef1-4b4b-b099-abde92f15145.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORAZEPAMLORAZEPAMA-S Medication Solutions823b1d71-a510-4d34-8015-60b55af23d782023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMProficient Rx LP5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1c956cc1-9217-46e0-80a3-7c811163d3f12021-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCa4fa14be-cef1-4b4b-b099-abde92f151452019-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 71610-199

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNa4fa14be-cef1-4b4b-b099-abde92f151452
197900lorazepam 0.5 MG Oral TabletSCDa4fa14be-cef1-4b4b-b099-abde92f151452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-199-107161001991010 TABLET in 1 BOTTLE (71610-199-10) 10 tablet2018-11-270000-00-00NoNoCurrent
71610-199-157161001991515 TABLET in 1 BOTTLE (71610-199-15) 15 tablet2018-11-270000-00-00NoNoCurrent
71610-199-207161001992020 TABLET in 1 BOTTLE (71610-199-20) 20 tablet2018-11-270000-00-00NoNoCurrent
71610-199-307161001993030 TABLET in 1 BOTTLE (71610-199-30) 30 tablet2018-11-270000-00-00NoNoCurrent
71610-199-457161001994545 TABLET in 1 BOTTLE (71610-199-45) 45 tablet2018-11-270000-00-00NoNoCurrent
71610-199-537161001995360 TABLET in 1 BOTTLE (71610-199-53) 60 tablet2018-11-270000-00-00NoNoCurrent
71610-199-557161001995575 TABLET in 1 BOTTLE (71610-199-55) 75 tablet2018-11-270000-00-00NoNoCurrent
71610-199-607161001996090 TABLET in 1 BOTTLE (71610-199-60) 90 tablet2018-11-270000-00-00NoNoCurrent
71610-199-7071610019970120 TABLET in 1 BOTTLE (71610-199-70) 120 tablet2018-11-270000-00-00NoNoCurrent
71610-199-7571610019975150 TABLET in 1 BOTTLE (71610-199-75) 150 tablet2018-11-270000-00-00NoNoCurrent
71610-199-8071610019980180 TABLET in 1 BOTTLE (71610-199-80) 180 tablet2018-11-270000-00-00NoNoCurrent
71610-199-9271610019992270 TABLET in 1 BOTTLE (71610-199-92) 270 tablet2018-11-270000-00-00NoNoCurrent