Alprazolam

Product NDC
69339-202
11-digit product format
693390202
Labeler code
69339
Product ID
69339-202_885d0fec-f1a6-42f4-8617-1d048cb15ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA200739
Marketing category
ANDA
Marketing start
2023-07-28
Substance
ALPRAZOLAM
Active strength
2 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321, 197322, 308047, 308048

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
69339-202-01Alprazolam100 in 1 BOTTLETABLET1003
69339-202-05Alprazolam500 in 1 BOTTLETABLET5003
69339-202-10Alprazolam1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-202ALPRAZOLAM TABLET [NATCO PHARMA USA LLC]2Current NDC, 3 package rows20231103_b3c55877-2538-4892-bdb1-d618c643d29c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNb3c55877-2538-4892-bdb1-d618c643d29c3
308048ALPRAZolam 0.5 MG Oral TabletPSNb3c55877-2538-4892-bdb1-d618c643d29c3
197321ALPRAZolam 1 MG Oral TabletPSNb3c55877-2538-4892-bdb1-d618c643d29c3
197322ALPRAZolam 2 MG Oral TabletPSNb3c55877-2538-4892-bdb1-d618c643d29c3
308047alprazolam 0.25 MG Oral TabletSCDb3c55877-2538-4892-bdb1-d618c643d29c3
308048alprazolam 0.5 MG Oral TabletSCDb3c55877-2538-4892-bdb1-d618c643d29c3
197321alprazolam 1 MG Oral TabletSCDb3c55877-2538-4892-bdb1-d618c643d29c3
197322alprazolam 2 MG Oral TabletSCDb3c55877-2538-4892-bdb1-d618c643d29c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-202-0169339020201100 TABLET in 1 BOTTLE (69339-202-01) 100 tablet2023-07-28NoNoCurrent
69339-202-0569339020205500 TABLET in 1 BOTTLE (69339-202-05) 500 tablet2023-07-28NoNoCurrent
69339-202-10693390202101000 TABLET in 1 BOTTLE (69339-202-10) 1000 tablet2023-07-28NoNoCurrent