FDA.reportPublic FDA data

ALPRAZOLAM

Product NDC
12634-607
11-digit product format
126340607
Labeler code
12634
Product ID
12634-607_60d3cc49-2b2b-4b64-bbfb-32814a6da433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
APOTHECA, INC
Application
ANDA074342
Marketing category
ANDA
Marketing start
2012-06-30
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
12634-607-712020-01-31C16284748780-19d75b9d0-3994-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-607-71ALPRAZOLAM30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [APOTHECA, INC]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [APOTHECA, INC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [APOTHECA, INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [APOTHECA, INC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [APOTHECA, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [APOTHECA, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [APOTHECA, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-607ALPRAZOLAM TABLET [APOTHECA, INC]2Legacy NDC, 1 package rows20141101_176bcb54-bc3c-423b-b636-c4d1bf156b65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN176bcb54-bc3c-423b-b636-c4d1bf156b652
197321alprazolam 1 MG Oral TabletSCD176bcb54-bc3c-423b-b636-c4d1bf156b652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-607-711263406077130 in 1 BOTTLEHistorical