FDA.reportPublic FDA data

Alprazolam

Product NDC
33261-741
11-digit product format
332610741
Labeler code
33261
Product ID
33261-741_25385136-ce02-4fd2-a88e-e27da4b0fc0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078387
Marketing category
ANDA
Marketing start
2009-12-03
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
2019-12-31
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
33261-741-072020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets
33261-741-202020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets
33261-741-302020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets
33261-741-452020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets
33261-741-602020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets
33261-741-902020-01-31C16284748780-19d75b9d0-0388-f424-e053-dadaa90a57ceAlprazolam Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-741-07Alprazolam7 in 1 BOTTLETABLET, EXTENDED RELEASE72
33261-741-20Alprazolam20 in 1 BOTTLETABLET, EXTENDED RELEASE202
33261-741-30Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE302
33261-741-45Alprazolam45 in 1 BOTTLETABLET, EXTENDED RELEASE452
33261-741-60Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE602
33261-741-90Alprazolam90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-741-45EA - Each33261-741a88d4a98-7972-4833-a347-4944a300d97012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-741ALPRAZOLAM TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 6 package rows20121004_f8103235-8cc0-4e81-8fe2-1846f91ce444.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSNf8103235-8cc0-4e81-8fe2-1846f91ce4442
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCDf8103235-8cc0-4e81-8fe2-1846f91ce4442
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSYf8103235-8cc0-4e81-8fe2-1846f91ce4442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-741-07332610741077 in 1 BOTTLEHistorical
33261-741-203326107412020 in 1 BOTTLEHistorical
33261-741-303326107413030 in 1 BOTTLEHistorical
33261-741-453326107414545 in 1 BOTTLEHistorical
33261-741-603326107416060 in 1 BOTTLEHistorical
33261-741-903326107419090 in 1 BOTTLEHistorical