Alprazolam

Product NDC
65862-678
11-digit product format
658620678
Labeler code
65862
Product ID
65862-678_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
1 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
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
65862-678-01Alprazolam100 in 1 BOTTLETABLET10010
65862-678-05Alprazolam500 in 1 BOTTLETABLET50010
65862-678-99Alprazolam1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-678ALPRAZOLAM 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
197321ALPRAZolam 1 MG Oral TabletPSNd8364af1-d23e-4cd7-9a81-077ae97a951a103
197321alprazolam 1 MG Oral TabletSCDd8364af1-d23e-4cd7-9a81-077ae97a951a103
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
197321ALPRAZolam 1 MG Oral TabletPSNf6dd8005-1d50-41bc-e053-6394a90ac45b5
197321alprazolam 1 MG Oral TabletSCDf6dd8005-1d50-41bc-e053-6394a90ac45b5
197321ALPRAZolam 1 MG Oral TabletPSNf7e63d96-2310-4ab1-e053-6294a90a86fc4
197321ALPRAZolam 1 MG Oral TabletPSNdc130aae-4510-4de7-a750-4a144e88208d4
197321alprazolam 1 MG Oral TabletSCDf7e63d96-2310-4ab1-e053-6294a90a86fc4
197321alprazolam 1 MG Oral TabletSCDdc130aae-4510-4de7-a750-4a144e88208d4
308047ALPRAZolam 0.25 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047ALPRAZolam 0.25 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
308048ALPRAZolam 0.5 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321ALPRAZolam 1 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321ALPRAZolam 1 MG Oral TabletPSN5111e57d-8920-6861-e063-6294a90a21941
197321ALPRAZolam 1 MG Oral TabletPSN3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321ALPRAZolam 1 MG Oral TabletPSNfc5fe795-6b41-aecf-e053-6394a90af5621
197321ALPRAZolam 1 MG Oral TabletPSN26f8b63c-6dad-8fac-e063-6394a90a54351
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 TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321alprazolam 1 MG Oral TabletSCDfc5fe795-6b41-aecf-e053-6394a90af5621
197321alprazolam 1 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321alprazolam 1 MG Oral TabletSCD5111e57d-8920-6861-e063-6294a90a21941
197321alprazolam 1 MG Oral TabletSCD3fa14fa4-45a7-6ef4-e063-6394a90a1dcd1
197321alprazolam 1 MG Oral TabletSCD26f8b63c-6dad-8fac-e063-6394a90a54351
197322alprazolam 2 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-678-0165862067801100 TABLET in 1 BOTTLE (65862-678-01) 100 tablet2015-07-310000-00-00NoNoCurrent
65862-678-0565862067805500 TABLET in 1 BOTTLE (65862-678-05) 500 tablet2015-07-310000-00-00NoNoCurrent
65862-678-49658620678494000 TABLET in 1 BAG (65862-678-49)4000 tablet31-JUL-15Current
65862-678-99658620678991000 TABLET in 1 BOTTLE (65862-678-99) 1000 tablet2015-07-310000-00-00NoNoCurrent