FDA.reportPublic FDA data

Lorazepam

Product NDC
67296-1060
11-digit product format
672961060
Labeler code
67296
Product ID
67296-1060_9c9ed8d1-9a71-e2d6-e053-2995a90a93ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077754
Marketing category
ANDA
Marketing start
2006-05-10
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1060IInactivated by FDA2026-08-03
excluded packagepackage67296-106067296-1060-1IInactivated by FDA2026-08-03
excluded packagepackage67296-106067296-1060-3IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077754-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2006-05-10
A077754-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2006-05-10
A077754-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2006-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077754-001AB
A077754-002AB
A077754-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10a50c72e98297…
2026-08-01 22:54:322026-06A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10a50c72e98297…
2026-08-01 22:54:322026-06A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077754-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077754-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077754-003AB1a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1060-12022-01-28C16284748780-1d6a99b39-ed93-a426-e053-dadaa90af4c24e409ad8-0090-1fe1-e054-00144ff8d46c
67296-1060-32022-01-28C16284748780-1d6a99b39-ed93-a426-e053-dadaa90af4c24e409ad8-0090-1fe1-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1060-1Lorazepam10 in 1 BOTTLETABLET103
67296-1060-3Lorazepam15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1060LORAZEPAM TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20200123_4e409ad8-0090-1fe1-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN4e409ad8-0090-1fe1-e054-00144ff8d46c3
197900lorazepam 0.5 MG Oral TabletSCD4e409ad8-0090-1fe1-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1060-16729610600110 TABLET in 1 BOTTLE (67296-1060-1) 10 tablet2006-05-100000-00-00NoNoCurrent
67296-1060-36729610600315 TABLET in 1 BOTTLE (67296-1060-3) 15 tablet2006-05-100000-00-00NoNoCurrent