Alprazolam

Product NDC
0781-1079
11-digit product format
007811079
Labeler code
0781
Product ID
0781-1079_4c8c7366-aa3b-4124-9d64-67fb0ead6e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 197322, 308047, 308048

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1079-01Alprazolam100 in 1 BOTTLETABLET10021
0781-1079-05Alprazolam500 in 1 BOTTLETABLET50021
0781-1079-10Alprazolam1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1079-01EA - Each0781-107909f80651-41cb-4294-a5ef-c08f4cb73ac312012-07-24
0781-1079-05EA - Each0781-107983c120f4-e035-4385-9f82-d4c7cb8a295412012-07-24
0781-1079-10EA - Each0781-1079abd97ae9-397b-4088-b663-7cc2256be74d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [SANDOZ INC]10
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [SANDOZ INC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [SANDOZ INC]10
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [SANDOZ INC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [SANDOZ INC]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [SANDOZ INC]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [SANDOZ INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [SANDOZ INC]10
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [SANDOZ INC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [SANDOZ INC]10
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PROFICIENT RX LP]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [UNIT DOSE SERVICES]2
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [STAT RX USA LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [STAT RX USA LLC]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [STAT RX USA LLC]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [STAT RX USA LLC]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [STAT RX USA LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [STAT RX USA LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [STAT RX USA LLC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [STAT RX USA LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1079ALPRAZOLAM TABLET [SANDOZ INC]21Current NDC, Legacy NDC, 3 package rows20241122_d9b0e228-17cf-40d7-b62e-5050311c571c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321ALPRAZolam 1 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322ALPRAZolam 2 MG Oral TabletPSN3c0cb60f-1c3a-48a6-ad16-f1435154841227
308047alprazolam 0.25 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321alprazolam 1 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197322alprazolam 2 MG Oral TabletSCD3c0cb60f-1c3a-48a6-ad16-f1435154841227
197321ALPRAZolam 1 MG Oral TabletPSN0ffcdbab-17e4-4395-8155-5b6ad00be6c226
197321alprazolam 1 MG Oral TabletSCD0ffcdbab-17e4-4395-8155-5b6ad00be6c226
308047ALPRAZolam 0.25 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
308048ALPRAZolam 0.5 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
197321ALPRAZolam 1 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
197322ALPRAZolam 2 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
308047alprazolam 0.25 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
308048alprazolam 0.5 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197321alprazolam 1 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197322alprazolam 2 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197321ALPRAZolam 1 MG Oral TabletPSNb39e2bc8-b691-0f4e-e053-2995a90a00fd7
197321alprazolam 1 MG Oral TabletSCDb39e2bc8-b691-0f4e-e053-2995a90a00fd7
308048ALPRAZolam 0.5 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321ALPRAZolam 1 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322ALPRAZolam 2 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
308048alprazolam 0.5 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321alprazolam 1 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322alprazolam 2 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321ALPRAZolam 1 MG Oral TabletPSN8d0575c8-5556-41ce-9b94-8c013ff690664
197321alprazolam 1 MG Oral TabletSCD8d0575c8-5556-41ce-9b94-8c013ff690664
197321ALPRAZolam 1 MG Oral TabletPSN8d801b8a-b203-7ea7-e053-2a95a90a40563
197321alprazolam 1 MG Oral TabletSCD8d801b8a-b203-7ea7-e053-2a95a90a40563
308047ALPRAZolam 0.25 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308048ALPRAZolam 0.5 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
197321ALPRAZolam 1 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
197321ALPRAZolam 1 MG Oral TabletPSN1b67c155-5a70-2202-e054-00144ff8d46c2
308047alprazolam 0.25 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308048alprazolam 0.5 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
197321alprazolam 1 MG Oral TabletSCD1b67c155-5a70-2202-e054-00144ff8d46c2
197321alprazolam 1 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308047ALPRAZolam 0.25 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
308047ALPRAZolam 0.25 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308048ALPRAZolam 0.5 MG Oral TabletPSN263d7c02-ca81-4035-9b3e-5104e8aff0861
308048ALPRAZolam 0.5 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
308048ALPRAZolam 0.5 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197321ALPRAZolam 1 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
197321ALPRAZolam 1 MG Oral TabletPSN263d7c02-ca81-4035-9b3e-5104e8aff0861
197321ALPRAZolam 1 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197321ALPRAZolam 1 MG Oral TabletPSN563e09db-2f3d-4ce8-b356-ae44477be6d01
197322ALPRAZolam 2 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
308048alprazolam 0.5 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
308048alprazolam 0.5 MG Oral TabletSCD263d7c02-ca81-4035-9b3e-5104e8aff0861
308048alprazolam 0.5 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
197321alprazolam 1 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197321alprazolam 1 MG Oral TabletSCD263d7c02-ca81-4035-9b3e-5104e8aff0861
197321alprazolam 1 MG Oral TabletSCD563e09db-2f3d-4ce8-b356-ae44477be6d01
197321alprazolam 1 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
197322alprazolam 2 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1079-0100781107901100 TABLET in 1 BOTTLE (0781-1079-01) 100 tablet1995-12-292027-03-19NoNoCurrent
0781-1079-0500781107905500 TABLET in 1 BOTTLE (0781-1079-05) 500 tablet1995-12-292027-03-19NoNoCurrent
0781-1079-10007811079101000 TABLET in 1 BOTTLE (0781-1079-10) 1000 tablet1995-12-292027-03-19NoNoCurrent