FDA.reportPublic FDA data

Alprazolam

Product NDC
65862-677
11-digit product format
658620677
Labeler code
65862
Product ID
65862-677_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
.5 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.5 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
65862-677-01Alprazolam100 in 1 BOTTLETABLET10010
65862-677-05Alprazolam500 in 1 BOTTLETABLET50010
65862-677-99Alprazolam1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-677ALPRAZOLAM 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
308048ALPRAZolam 0.5 MG Oral TabletPSN2bd0d4c6-0fde-46f2-bb13-da25d50427df106
308048alprazolam 0.5 MG Oral TabletSCD2bd0d4c6-0fde-46f2-bb13-da25d50427df106
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
308048ALPRAZolam 0.5 MG Oral TabletPSNf6dd0e94-4a79-769f-e053-6394a90a5ae65
308048alprazolam 0.5 MG Oral TabletSCDf6dd0e94-4a79-769f-e053-6394a90a5ae65
308048ALPRAZolam 0.5 MG Oral TabletPSN73c1d1dc-ade2-4bb4-b109-83bd63acd15c4
308048alprazolam 0.5 MG Oral TabletSCD73c1d1dc-ade2-4bb4-b109-83bd63acd15c4
308048ALPRAZolam 0.5 MG Oral TabletPSNf7e5cdb6-e3ca-27e2-e053-6394a90a721f3
308048alprazolam 0.5 MG Oral TabletSCDf7e5cdb6-e3ca-27e2-e053-6394a90a721f3
308047ALPRAZolam 0.25 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308047ALPRAZolam 0.25 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN68e6ef8c-4104-4636-9719-6aa386c892d91
308048ALPRAZolam 0.5 MG Oral TabletPSN509a8a86-d61c-3f05-e063-6394a90a52ca1
308048ALPRAZolam 0.5 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308048ALPRAZolam 0.5 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN14960c0c-555f-acc1-e063-6394a90a232a1
308048ALPRAZolam 0.5 MG Oral TabletPSN315b8cf2-01a0-3f7d-e063-6394a90a39b51
197321ALPRAZolam 1 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321ALPRAZolam 1 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197322ALPRAZolam 2 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308048alprazolam 0.5 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048alprazolam 0.5 MG Oral TabletSCD68e6ef8c-4104-4636-9719-6aa386c892d91
308048alprazolam 0.5 MG Oral TabletSCD509a8a86-d61c-3f05-e063-6394a90a52ca1
308048alprazolam 0.5 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308048alprazolam 0.5 MG Oral TabletSCD315b8cf2-01a0-3f7d-e063-6394a90a39b51
308048alprazolam 0.5 MG Oral TabletSCD14960c0c-555f-acc1-e063-6394a90a232a1
197321alprazolam 1 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321alprazolam 1 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197322alprazolam 2 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-677-0165862067701100 TABLET in 1 BOTTLE (65862-677-01) 100 tablet2015-07-310000-00-00NoNoCurrent
65862-677-0565862067705500 TABLET in 1 BOTTLE (65862-677-05) 500 tablet2015-07-310000-00-00NoNoCurrent
65862-677-49658620677494000 TABLET in 1 BAG (65862-677-49)4000 tablet31-JUL-15Current
65862-677-99658620677991000 TABLET in 1 BOTTLE (65862-677-99) 1000 tablet2015-07-310000-00-00NoNoCurrent