FDA.reportPublic FDA data

Lorazepam

Product NDC
71205-166
11-digit product format
712050166
Labeler code
71205
Product ID
71205-166_c17cc1a9-f6a9-4fcd-ba74-f7291a0e43fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
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
71205-166-02Lorazepam2 in 1 BOTTLETABLET24
71205-166-10Lorazepam10 in 1 BOTTLETABLET104
71205-166-15Lorazepam15 in 1 BOTTLETABLET154
71205-166-30Lorazepam30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-166-02EA - Each71205-16692d5dd63-ab24-4ba0-9b1e-f31ff30315bb12019-02-13
71205-166-10EA - Each71205-1660bf6999a-8e43-4369-8b28-9b0826bc209612024-08-12
71205-166-15EA - Each71205-1661d8d18e0-6e4f-4ab3-ac36-f39fa5cb948712019-02-13
71205-166-30EA - Each71205-166d53be22b-5b00-4a41-bf38-5f4f88ba384d12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-166LORAZEPAM TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240518_e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNe9052b38-3c9f-4c84-9a0d-98bd99b9ddfd4
197900lorazepam 0.5 MG Oral TabletSCDe9052b38-3c9f-4c84-9a0d-98bd99b9ddfd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-166-02712050166022 TABLET in 1 BOTTLE (71205-166-02) 2 tablet2018-12-010000-00-00NoNoCurrent
71205-166-03712050166033 TABLET in 1 BOTTLE (71205-166-03) 3 tablet2018-12-010000-00-00NoNoCurrent
71205-166-107120501661010 TABLET in 1 BOTTLE (71205-166-10) 10 tablet2024-05-16NoNoHistorical
71205-166-157120501661515 TABLET in 1 BOTTLE (71205-166-15) 15 tablet2018-12-010000-00-00NoNoCurrent
71205-166-307120501663030 TABLET in 1 BOTTLE (71205-166-30) 30 tablet2018-12-010000-00-00NoNoCurrent
71205-166-607120501666060 TABLET in 1 BOTTLE (71205-166-60) 60 tablet2018-12-010000-00-00NoNoCurrent
71205-166-907120501669090 TABLET in 1 BOTTLE (71205-166-90) 90 tablet2018-12-010000-00-00NoNoCurrent