FDA.reportPublic FDA data

Alprazolam

Product NDC
0781-1089
11-digit product format
007811089
Labeler code
0781
Product ID
0781-1089_4c8c7366-aa3b-4124-9d64-67fb0ead6e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
2 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
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1089-01Alprazolam100 in 1 BOTTLETABLET10021
0781-1089-05Alprazolam500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1089-01EA - Each0781-108908d97cf7-1312-4ce2-98a6-8098a0dfc30712012-07-24
0781-1089-05EA - Each0781-1089889b2c15-1be7-43a6-a1d6-849252533fc712012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1089ALPRAZOLAM TABLET [SANDOZ INC]21Current NDC, Legacy NDC, 2 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
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
197322ALPRAZolam 2 MG Oral TabletPSN7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed321
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 TabletSCD7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed321
197322alprazolam 2 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197322ALPRAZolam 2 MG Oral TabletPSNb0000772-2514-45a2-a75d-1bbb13c299899
197322alprazolam 2 MG Oral TabletSCDb0000772-2514-45a2-a75d-1bbb13c299899
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
197322ALPRAZolam 2 MG Oral TabletPSN60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec92
197322alprazolam 2 MG Oral TabletSCD60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec92
308047ALPRAZolam 0.25 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308048ALPRAZolam 0.5 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197321ALPRAZolam 1 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197322ALPRAZolam 2 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
308048alprazolam 0.5 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197321alprazolam 1 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197322alprazolam 2 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1089-0100781108901100 TABLET in 1 BOTTLE (0781-1089-01) 100 tablet1998-03-252027-03-19NoNoCurrent
0781-1089-0500781108905500 TABLET in 1 BOTTLE (0781-1089-05) 500 tablet1998-03-252027-03-19NoNoCurrent