FDA.reportPublic FDA data

Alprazolam C-IV

Product NDC
72189-443
11-digit product format
721890443
Labeler code
72189
Product ID
72189-443_4c4ba26d-9b7b-5ee7-e063-6294a90a801d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam C-IV
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203346
Marketing category
ANDA
Marketing start
2023-03-14
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam C-IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321

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
72189-443-30Alprazolam C-IV30 in 1 BOTTLETABLET305
72189-443-60Alprazolam C-IV60 in 1 BOTTLETABLET605
72189-443-90Alprazolam C-IV90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-443-30EA - Each72189-443284d0e3e-9e76-45f4-a7d9-6e3f1fe8061e12023-04-07
72189-443-60EA - Each72189-443977c548f-ca70-4c4e-a398-d3270b24bf4812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-443ALPRAZOLAM C-IV TABLET [DIRECT_RX]4Current NDC, 3 package rows20250123_f6dd8005-1d50-41bc-e053-6394a90ac45b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSNf6dd8005-1d50-41bc-e053-6394a90ac45b5
197321alprazolam 1 MG Oral TabletSCDf6dd8005-1d50-41bc-e053-6394a90ac45b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-443-307218904433030 TABLET in 1 BOTTLE (72189-443-30) 30 tablet2023-03-14NoNoHistorical
72189-443-607218904436060 TABLET in 1 BOTTLE (72189-443-60) 60 tablet2023-03-14NoNoHistorical
72189-443-907218904439090 TABLET in 1 BOTTLE (72189-443-90) 90 tablet2023-03-14NoNoHistorical