FDA.reportPublic FDA data

Lorazepam

Product NDC
71205-756
11-digit product format
712050756
Labeler code
71205
Product ID
71205-756_7d33eb18-1504-43fc-b01d-8eb455759eb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072926
Marketing category
ANDA
Marketing start
2021-10-11
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
71205-756-10Lorazepam10 in 1 BOTTLE, PLASTICTABLET102
71205-756-15Lorazepam15 in 1 BOTTLE, PLASTICTABLET152
71205-756-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET302
71205-756-60Lorazepam60 in 1 BOTTLE, PLASTICTABLET602
71205-756-90Lorazepam90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-756-10EA - Each71205-756182df5d6-7945-4b2b-8fe5-2dc35e8ad0ee12023-04-07
71205-756-15EA - Each71205-756660ac7b4-6706-46fe-8c2a-bcb8d207ef8912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-756LORAZEPAM TABLET [PROFICIENT RX LP]2Current NDC, 5 package rows20230306_a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692
197900lorazepam 0.5 MG Oral TabletSCDa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-756-107120507561010 TABLET in 1 BOTTLE, PLASTIC (71205-756-10) 10 tablet2023-02-23NoNoCurrent
71205-756-157120507561515 TABLET in 1 BOTTLE, PLASTIC (71205-756-15) 15 tablet2023-02-02NoNoCurrent
71205-756-307120507563030 TABLET in 1 BOTTLE, PLASTIC (71205-756-30) 30 tablet2023-02-02NoNoCurrent
71205-756-607120507566060 TABLET in 1 BOTTLE, PLASTIC (71205-756-60) 60 tablet2023-02-02NoNoCurrent
71205-756-907120507569090 TABLET in 1 BOTTLE, PLASTIC (71205-756-90) 90 tablet2023-02-02NoNoCurrent