FDA.reportPublic FDA data

Alprazolam

Product NDC
65862-676
11-digit product format
658620676
Labeler code
65862
Product ID
65862-676_7527aeb7-8912-404d-afb7-8c692c84422b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203346
Marketing category
ANDA
Marketing start
2015-07-31
Substance
ALPRAZOLAM
Active strength
.25 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.25 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
65862-676-01Alprazolam100 in 1 BOTTLETABLET10010
65862-676-05Alprazolam500 in 1 BOTTLETABLET50010
65862-676-99Alprazolam1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-676-01EA - Each65862-676d3d49e0f-32fb-4d46-af8f-3249a811bb4f12020-04-20
65862-676-05EA - Each65862-676746bb045-92c9-4e75-9052-5375a69cd1aa12020-04-20
65862-676-99EA - Each65862-676a45929e3-4267-47db-addc-970267e4ccc712018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-676ALPRAZOLAM TABLET [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 3 package rows20230310_d2fd0b3e-9b78-44d0-82a6-96d6c6238750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN0e2644fa-8334-4209-a63d-2466b5ab55b4103
308047alprazolam 0.25 MG Oral TabletSCD0e2644fa-8334-4209-a63d-2466b5ab55b4103
308047ALPRAZolam 0.25 MG Oral TabletPSN4203d3fe-916e-41af-9daf-f58f4fed6f9c13
308047alprazolam 0.25 MG Oral TabletSCD4203d3fe-916e-41af-9daf-f58f4fed6f9c13
308047ALPRAZolam 0.25 MG Oral TabletPSNd2fd0b3e-9b78-44d0-82a6-96d6c623875010
308048ALPRAZolam 0.5 MG Oral TabletPSNd2fd0b3e-9b78-44d0-82a6-96d6c623875010
197321ALPRAZolam 1 MG Oral TabletPSNd2fd0b3e-9b78-44d0-82a6-96d6c623875010
197322ALPRAZolam 2 MG Oral TabletPSNd2fd0b3e-9b78-44d0-82a6-96d6c623875010
308047alprazolam 0.25 MG Oral TabletSCDd2fd0b3e-9b78-44d0-82a6-96d6c623875010
308048alprazolam 0.5 MG Oral TabletSCDd2fd0b3e-9b78-44d0-82a6-96d6c623875010
197321alprazolam 1 MG Oral TabletSCDd2fd0b3e-9b78-44d0-82a6-96d6c623875010
197322alprazolam 2 MG Oral TabletSCDd2fd0b3e-9b78-44d0-82a6-96d6c623875010
308047ALPRAZolam 0.25 MG Oral TabletPSNea95d182-453b-4c43-8402-d65c488d55f26
308048ALPRAZolam 0.5 MG Oral TabletPSNea95d182-453b-4c43-8402-d65c488d55f26
308047alprazolam 0.25 MG Oral TabletSCDea95d182-453b-4c43-8402-d65c488d55f26
308048alprazolam 0.5 MG Oral TabletSCDea95d182-453b-4c43-8402-d65c488d55f26
308047ALPRAZolam 0.25 MG Oral TabletPSN78682252-e448-4b20-b49d-27c2c70e4cb34
308047alprazolam 0.25 MG Oral TabletSCD78682252-e448-4b20-b49d-27c2c70e4cb34
308047ALPRAZolam 0.25 MG Oral TabletPSN02840ea6-e4a0-96a0-e063-6394a90a19ae3
308047alprazolam 0.25 MG Oral TabletSCD02840ea6-e4a0-96a0-e063-6394a90a19ae3
308047ALPRAZolam 0.25 MG Oral TabletPSN01f8155d-721f-70ae-e063-6394a90aeec52
308047ALPRAZolam 0.25 MG Oral TabletPSN25174ee5-a86e-ab97-e063-6394a90acd872
308047alprazolam 0.25 MG Oral TabletSCD01f8155d-721f-70ae-e063-6394a90aeec52
308047alprazolam 0.25 MG Oral TabletSCD25174ee5-a86e-ab97-e063-6394a90acd872
308047ALPRAZolam 0.25 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047ALPRAZolam 0.25 MG Oral TabletPSN315b5782-969a-4324-e063-6394a90acf371
308047ALPRAZolam 0.25 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308047ALPRAZolam 0.25 MG Oral TabletPSNc6795ed8-af28-41f4-b85b-48e1fe9d03691
308048ALPRAZolam 0.5 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321ALPRAZolam 1 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321ALPRAZolam 1 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322ALPRAZolam 2 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCDc6795ed8-af28-41f4-b85b-48e1fe9d03691
308047alprazolam 0.25 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308047alprazolam 0.25 MG Oral TabletSCD315b5782-969a-4324-e063-6394a90acf371
308048alprazolam 0.5 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308048alprazolam 0.5 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321alprazolam 1 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321alprazolam 1 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322alprazolam 2 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-676-0165862067601100 TABLET in 1 BOTTLE (65862-676-01) 100 tablet2015-07-310000-00-00NoNoCurrent
65862-676-0565862067605500 TABLET in 1 BOTTLE (65862-676-05) 500 tablet2015-07-310000-00-00NoNoCurrent
65862-676-49658620676494000 TABLET in 1 BAG (65862-676-49)4000 tablet31-JUL-15Current
65862-676-99658620676991000 TABLET in 1 BOTTLE (65862-676-99) 1000 tablet2015-07-310000-00-00NoNoCurrent