FDA.reportPublic FDA data

Alprazolam

Product NDC
76420-654
11-digit product format
764200654
Labeler code
76420
Product ID
76420-654_0e42e402-85e4-30a1-e063-6394a90a142c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090871
Marketing category
ANDA
Marketing start
2011-06-07
Substance
ALPRAZOLAM
Active strength
3 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
Alprazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui433798, 433799, 433800, 433801

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-654-30Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE301
76420-654-60Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE601
76420-654-90Alprazolam90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-654ALPRAZOLAM TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.]1Current NDC, 3 package rows20240107_5d839a8b-0f45-42bf-acc1-2bd28f948e53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-654-307642006543030 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-654-30) 2024-01-05NoNoHistorical
76420-654-607642006546060 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-654-60) 2024-01-05NoNoHistorical
76420-654-907642006549090 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-654-90) 2024-01-05NoNoHistorical