FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-828
11-digit product format
716100828
Labeler code
71610
Product ID
71610-828_32454287-89bf-f90f-e063-6294a90a3091
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
2023-10-26
Substance
LORAZEPAM
Active strength
1 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
LORAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197901

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
71610-828-10Lorazepam10 in 1 BOTTLETABLET104
71610-828-15Lorazepam15 in 1 BOTTLETABLET154
71610-828-28Lorazepam28 in 1 BOTTLETABLET284
71610-828-30Lorazepam30 in 1 BOTTLETABLET304
71610-828-45Lorazepam45 in 1 BOTTLETABLET454
71610-828-53Lorazepam60 in 1 BOTTLETABLET604
71610-828-55Lorazepam75 in 1 BOTTLETABLET754
71610-828-60Lorazepam90 in 1 BOTTLETABLET904
71610-828-70Lorazepam120 in 1 BOTTLETABLET1204
71610-828-75Lorazepam150 in 1 BOTTLETABLET1504
71610-828-80Lorazepam180 in 1 BOTTLETABLET1804
71610-828-92Lorazepam270 in 1 BOTTLETABLET2704

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-828-10EA - Each71610-828117ce74b-2f37-4439-888e-f3e4fbd9dee612024-07-12
71610-828-15EA - Each71610-8288e9b879f-a6f5-4730-940e-cc73ae7ca4d112024-08-12
71610-828-28EA - Each71610-828ff341f3a-ab48-4a0b-9c33-eaad8d6d790912024-07-12
71610-828-30EA - Each71610-82844b8c5bb-17ae-4d00-9532-a169bf51689012024-07-12
71610-828-45EA - Each71610-8288ae30ce2-abf9-4b80-8d58-090c78aea3ea12024-07-12
71610-828-53EA - Each71610-828c813123a-94e7-4331-a4fc-3febb293dcb112024-07-12
71610-828-55EA - Each71610-828ccc89cb5-e3ac-4a3b-9b8f-5613a7d3cd9a12025-06-13
71610-828-60EA - Each71610-82862bc6286-9fe8-4794-aa67-33b925cd754212024-07-12
71610-828-70EA - Each71610-828ca7a4fe1-ca7f-4f75-abc9-df276921535512024-08-12
71610-828-75EA - Each71610-8283a829698-38ce-4862-b128-b0a1e1884a8512025-02-10
71610-828-80EA - Each71610-82801646c33-2c51-46cf-8c0f-bc8b9d20eca012024-07-12
71610-828-92EA - Each71610-8283e98c449-4f5d-4e10-8745-fd28f60a08e712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-828LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]4Current NDC, 12 package rows20250410_1791d5c9-9004-5c4b-e063-6294a90adf3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN1791d5c9-9004-5c4b-e063-6294a90adf3d4
197901lorazepam 1 MG Oral TabletSCD1791d5c9-9004-5c4b-e063-6294a90adf3d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-828-107161008281010 TABLET in 1 BOTTLE (71610-828-10) 10 tablet2024-05-02NoNoHistorical
71610-828-157161008281515 TABLET in 1 BOTTLE (71610-828-15) 15 tablet2024-06-14NoNoHistorical
71610-828-287161008282828 TABLET in 1 BOTTLE (71610-828-28) 28 tablet2024-05-02NoNoHistorical
71610-828-307161008283030 TABLET in 1 BOTTLE (71610-828-30) 30 tablet2024-05-02NoNoHistorical
71610-828-457161008284545 TABLET in 1 BOTTLE (71610-828-45) 45 tablet2024-05-02NoNoHistorical
71610-828-537161008285360 TABLET in 1 BOTTLE (71610-828-53) 60 tablet2024-05-02NoNoHistorical
71610-828-557161008285575 TABLET in 1 BOTTLE (71610-828-55) 75 tablet2025-04-04NoNoHistorical
71610-828-607161008286090 TABLET in 1 BOTTLE (71610-828-60) 90 tablet2024-05-02NoNoHistorical
71610-828-7071610082870120 TABLET in 1 BOTTLE (71610-828-70) 120 tablet2024-06-14NoNoHistorical
71610-828-7571610082875150 TABLET in 1 BOTTLE (71610-828-75) 150 tablet2024-12-06NoNoHistorical
71610-828-8071610082880180 TABLET in 1 BOTTLE (71610-828-80) 180 tablet2024-05-02NoNoHistorical
71610-828-9271610082892270 TABLET in 1 BOTTLE (71610-828-92) 270 tablet2024-05-02NoNoHistorical