FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-764
11-digit product format
716100764
Labeler code
71610
Product ID
71610-764_0ce0322d-f996-d9e9-e063-6294a90a7386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076045
Marketing category
ANDA
Marketing start
2023-12-19
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

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 Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900

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
71610-764-10Lorazepam10 in 1 BOTTLETABLET101
71610-764-15Lorazepam15 in 1 BOTTLETABLET151
71610-764-20Lorazepam20 in 1 BOTTLETABLET201
71610-764-28Lorazepam28 in 1 BOTTLETABLET281
71610-764-30Lorazepam30 in 1 BOTTLETABLET301
71610-764-45Lorazepam45 in 1 BOTTLETABLET451
71610-764-53Lorazepam60 in 1 BOTTLETABLET601
71610-764-60Lorazepam90 in 1 BOTTLETABLET901
71610-764-70Lorazepam120 in 1 BOTTLETABLET1201
71610-764-75Lorazepam150 in 1 BOTTLETABLET1501
71610-764-80Lorazepam180 in 1 BOTTLETABLET1801
71610-764-92Lorazepam270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-764-10EA - Each71610-76407dbbca9-2870-4153-9e84-52ea6271d56012024-02-14
71610-764-15EA - Each71610-764a730e991-5b2a-4fb9-a81e-0e5bb1bb8c2512024-02-14
71610-764-20EA - Each71610-764fc9203d1-ab93-42c3-bc8f-ea27c4febc4c12024-02-14
71610-764-28EA - Each71610-764cf27cf8c-0e0f-497e-94b6-1d2c1a15101612024-02-14
71610-764-30EA - Each71610-764a01e1af0-3f60-40d4-b3fe-0976ed85885812024-02-14
71610-764-45EA - Each71610-764f7febd15-b98e-4822-939a-69a5fd81891d12024-02-14
71610-764-53EA - Each71610-7644b8c1ff8-f8ea-4b26-a1ed-a3623459edd512024-02-14
71610-764-60EA - Each71610-764c5d04ce5-577c-4768-bb4b-4c664d43b2d012024-02-14
71610-764-70EA - Each71610-764cb9b3bcf-6fbe-44ba-aefb-eff45e954f1312024-02-14
71610-764-75EA - Each71610-764affd859b-adff-4735-a424-5515a0ace5ba12024-02-14
71610-764-80EA - Each71610-764f7d13944-db91-4cbb-bfc7-38dfba2cf30412024-02-14
71610-764-92EA - Each71610-7644458819a-bef5-42c7-b64d-ab33dd8f832f12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-764LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 12 package rows20231220_0ce02d7d-d855-c73f-e063-6294a90abe93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN0ce02d7d-d855-c73f-e063-6294a90abe931
197900lorazepam 0.5 MG Oral TabletSCD0ce02d7d-d855-c73f-e063-6294a90abe931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-764-107161007641010 TABLET in 1 BOTTLE (71610-764-10) 10 tablet2023-12-19NoNoHistorical
71610-764-157161007641515 TABLET in 1 BOTTLE (71610-764-15) 15 tablet2023-12-19NoNoHistorical
71610-764-207161007642020 TABLET in 1 BOTTLE (71610-764-20) 20 tablet2023-12-19NoNoHistorical
71610-764-287161007642828 TABLET in 1 BOTTLE (71610-764-28) 28 tablet2023-12-19NoNoHistorical
71610-764-307161007643030 TABLET in 1 BOTTLE (71610-764-30) 30 tablet2023-12-19NoNoHistorical
71610-764-457161007644545 TABLET in 1 BOTTLE (71610-764-45) 45 tablet2023-12-19NoNoHistorical
71610-764-537161007645360 TABLET in 1 BOTTLE (71610-764-53) 60 tablet2023-12-19NoNoHistorical
71610-764-607161007646090 TABLET in 1 BOTTLE (71610-764-60) 90 tablet2023-12-19NoNoHistorical
71610-764-7071610076470120 TABLET in 1 BOTTLE (71610-764-70) 120 tablet2023-12-19NoNoHistorical
71610-764-7571610076475150 TABLET in 1 BOTTLE (71610-764-75) 150 tablet2023-12-19NoNoHistorical
71610-764-8071610076480180 TABLET in 1 BOTTLE (71610-764-80) 180 tablet2023-12-19NoNoHistorical
71610-764-9271610076492270 TABLET in 1 BOTTLE (71610-764-92) 270 tablet2023-12-19NoNoHistorical