FDA.reportPublic FDA data

Alprazolam

Product NDC
71610-734
11-digit product format
716100734
Labeler code
71610
Product ID
71610-734_18a18d8e-9c73-4ba6-b05a-b7aae1e82fc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
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
Rxcui308048

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
71610-734-15Alprazolam15 in 1 BOTTLETABLET152
71610-734-30Alprazolam30 in 1 BOTTLETABLET302
71610-734-45Alprazolam45 in 1 BOTTLETABLET452
71610-734-53Alprazolam60 in 1 BOTTLETABLET602
71610-734-60Alprazolam90 in 1 BOTTLETABLET902
71610-734-70Alprazolam120 in 1 BOTTLETABLET1202
71610-734-75Alprazolam150 in 1 BOTTLETABLET1502
71610-734-80Alprazolam180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-734-15EA - Each71610-734e2cf1d43-2a0f-4d87-bffd-ba25ecbd359d12023-12-05
71610-734-30EA - Each71610-7342a61e592-fa55-44b0-9dd9-98c220542e6f12023-12-05
71610-734-45EA - Each71610-734b84206d8-df21-468c-aff4-8d07eac6c27312023-12-05
71610-734-53EA - Each71610-73441693d75-8f1e-4110-9a79-f465c5d6decd12023-12-05
71610-734-60EA - Each71610-7348cc32d92-879a-4bc2-b1b4-e860cac0242c12023-12-05
71610-734-70EA - Each71610-73410d81ac7-e9b1-437f-a444-53cb3c172d3412023-12-05
71610-734-75EA - Each71610-7348ef6cd13-ccca-4db0-bdb9-471fd2a41c5c12023-12-05
71610-734-80EA - Each71610-734e568e4f1-a4a7-4ad5-adc3-9905800eca3312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-734ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 8 package rows20230916_f95f4030-e8e0-416f-951d-c4dac09f386a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNf95f4030-e8e0-416f-951d-c4dac09f386a2
308048alprazolam 0.5 MG Oral TabletSCDf95f4030-e8e0-416f-951d-c4dac09f386a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-734-157161007341515 TABLET in 1 BOTTLE (71610-734-15) 15 tablet2023-09-12NoNoHistorical
71610-734-307161007343030 TABLET in 1 BOTTLE (71610-734-30) 30 tablet2023-09-12NoNoHistorical
71610-734-457161007344545 TABLET in 1 BOTTLE (71610-734-45) 45 tablet2023-09-12NoNoHistorical
71610-734-537161007345360 TABLET in 1 BOTTLE (71610-734-53) 60 tablet2023-09-12NoNoHistorical
71610-734-607161007346090 TABLET in 1 BOTTLE (71610-734-60) 90 tablet2023-09-12NoNoHistorical
71610-734-7071610073470120 TABLET in 1 BOTTLE (71610-734-70) 120 tablet2023-09-12NoNoHistorical
71610-734-7571610073475150 TABLET in 1 BOTTLE (71610-734-75) 150 tablet2023-09-12NoNoHistorical
71610-734-8071610073480180 TABLET in 1 BOTTLE (71610-734-80) 180 tablet2023-09-12NoNoHistorical