FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
72189-029
11-digit product format
721890029
Labeler code
72189
Product ID
72189-029_91d3dd5d-9b81-5d32-e053-2995a90a8096
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090871
Marketing category
ANDA
Marketing start
2019-09-05
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-029-302023-01-30C16284748780-1f386c64a-319f-0266-e053-dadaa90a7c1aALPRAZOLAM
72189-029-602023-01-30C16284748780-1f386c64a-41bb-0266-e053-dadaa90a7c1aALPRAZOLAM
72189-029-902023-01-30C16284748780-1f386c649-a07a-0266-e053-dadaa90a7c1aALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-029-30ALPRAZOLAM30 in 1 BOTTLETABLET, EXTENDED RELEASE301
72189-029-60ALPRAZOLAM60 in 1 BOTTLETABLET, EXTENDED RELEASE601
72189-029-90ALPRAZOLAM90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-029-30EA - Each72189-029c469bff1-9df1-4e55-ae60-faad54ab3edb12019-10-07
72189-029-60EA - Each72189-029dfd38a09-b0a7-459a-a5b2-f24daff2797712019-10-07
72189-029-90EA - Each72189-02966dc37ea-0f39-4831-a5f2-7f3c6f2decb812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91d3dd5d-9b80-5d32-e053-2995a90a8096.zip
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91d4bc67-31a7-bd2e-e053-2a95a90a8632.zip
72189-029ALPRAZOLAM TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190907_91e22909-eebc-e3ae-e053-2a95a90a3e94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91d3dd5d-9b80-5d32-e053-2995a90a80961
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91d4bc67-31a7-bd2e-e053-2a95a90a86321
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN91e22909-eebc-e3ae-e053-2a95a90a3e941
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91d3dd5d-9b80-5d32-e053-2995a90a80961
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91d4bc67-31a7-bd2e-e053-2a95a90a86321
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD91e22909-eebc-e3ae-e053-2a95a90a3e941
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91d3dd5d-9b80-5d32-e053-2995a90a80961
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91d4bc67-31a7-bd2e-e053-2a95a90a86321
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY91e22909-eebc-e3ae-e053-2a95a90a3e941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-029-307218900293030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-029-30) 2019-09-050000-00-00NoNoCurrent
72189-029-607218900296060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-029-60) 2019-09-060000-00-00NoNoCurrent
72189-029-907218900299090 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-029-90) 2019-09-050000-00-00NoNoCurrent