FDA.reportPublic FDA data

Alprazolam

Product NDC
33261-004
11-digit product format
332610004
Labeler code
33261
Product ID
33261-004_93729350-108f-4474-811d-9e4ca0294eac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074174
Marketing category
ANDA
Marketing start
2007-03-28
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
33261-004-002020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-022020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-102020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-152020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-302020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-422020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-452020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-602020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only
33261-004-902020-01-31C16284748780-19d75b9cf-d9d0-f424-e053-dadaa90a57ceALPRAZOLAM TABLETS, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-004-00Alprazolam100 in 1 BOTTLE, PLASTICTABLET1001
33261-004-02Alprazolam120 in 1 BOTTLE, PLASTICTABLET1201
33261-004-10Alprazolam10 in 1 BOTTLE, PLASTICTABLET101
33261-004-15Alprazolam15 in 1 BOTTLE, PLASTICTABLET151
33261-004-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET301
33261-004-42Alprazolam42 in 1 BOTTLE, PLASTICTABLET421
33261-004-45Alprazolam45 in 1 BOTTLE, PLASTICTABLET451
33261-004-60Alprazolam60 in 1 BOTTLE, PLASTICTABLET601
33261-004-90Alprazolam90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-004-02EA - Each33261-004426e780c-cc20-4a6a-baa7-52e6865b445e12015-10-02
33261-004-30EA - Each33261-00455e2c20c-f122-4767-bdfe-d5a4a0f5a74f12015-10-02
33261-004-60EA - Each33261-004da93b592-e2c7-46a3-84c6-06edda07d40012015-10-02
33261-004-90EA - Each33261-0048c5dfd60-7133-4d1c-84db-85972561b6a012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-004ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 9 package rows20131204_fd3d0e37-470d-4216-8070-24a206930eac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
308048ALPRAZolam 0.5 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
197321ALPRAZolam 1 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
197322ALPRAZolam 2 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
308047alprazolam 0.25 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
308048alprazolam 0.5 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197321alprazolam 1 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197322alprazolam 2 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-004-0033261000400100 in 1 BOTTLE, PLASTICHistorical
33261-004-0233261000402120 in 1 BOTTLE, PLASTICHistorical
33261-004-103326100041010 in 1 BOTTLE, PLASTICHistorical
33261-004-153326100041515 in 1 BOTTLE, PLASTICHistorical
33261-004-303326100043030 in 1 BOTTLE, PLASTICHistorical
33261-004-423326100044242 in 1 BOTTLE, PLASTICHistorical
33261-004-453326100044545 in 1 BOTTLE, PLASTICHistorical
33261-004-603326100046060 in 1 BOTTLE, PLASTICHistorical
33261-004-903326100049090 in 1 BOTTLE, PLASTICHistorical