FDA.reportPublic FDA data

Alprazolam

Product NDC
10544-155
11-digit product format
105440155
Labeler code
10544
Product ID
10544-155_11f616bd-5f65-554a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074174
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
0 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
10544-155-302020-01-31C16284748780-19d75b9d0-02d7-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
10544-155-602020-01-31C16284748780-19d75b9d0-02d7-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
10544-155-902020-01-31C16284748780-19d75b9d0-02d7-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-155-30Alprazolam30 in 1 BOTTLETABLET302
10544-155-60Alprazolam60 in 1 BOTTLETABLET602
10544-155-90Alprazolam90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-155-30EA - Each10544-1550c7b7f20-05da-4710-9f30-b91a6c8e864e12015-10-02
10544-155-60EA - Each10544-15507766d03-7684-4385-9f74-a011eb6a225b12015-10-02
10544-155-90EA - Each10544-155b9dc5e70-4f4f-4a74-8602-d9180bd99b5912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-155ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 3 package rows20150323_11f5cd79-ddac-3e16-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN11f5cd79-ddac-3e16-e054-00144ff8d46c2
308047alprazolam 0.25 MG Oral TabletSCD11f5cd79-ddac-3e16-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-155-301054401553030 in 1 BOTTLEHistorical
10544-155-601054401556060 in 1 BOTTLEHistorical
10544-155-901054401559090 in 1 BOTTLEHistorical