FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-9666
11-digit product format
713359666
Labeler code
71335
Product ID
71335-9666_b93d3341-c70b-4da1-bef6-6c5106c21dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
ALPRAZOLAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui308048

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
71335-9666-0Alprazolam10 in 1 BOTTLETABLET10106
71335-9666-1Alprazolam15 in 1 BOTTLETABLET15106
71335-9666-2Alprazolam30 in 1 BOTTLETABLET30106
71335-9666-3Alprazolam20 in 1 BOTTLETABLET20106
71335-9666-4Alprazolam100 in 1 BOTTLETABLET100106
71335-9666-5Alprazolam90 in 1 BOTTLETABLET90106
71335-9666-6Alprazolam60 in 1 BOTTLETABLET60106
71335-9666-7Alprazolam120 in 1 BOTTLETABLET120106
71335-9666-8Alprazolam28 in 1 BOTTLETABLET28106
71335-9666-9Alprazolam2 in 1 BOTTLETABLET2106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9666-1EA - Each71335-9666cbb64355-56a2-4c15-9d97-e033a072936512023-09-05
71335-9666-2EA - Each71335-9666ac185d66-c68d-4b51-a58d-85f9d5020ab812025-05-14
71335-9666-5EA - Each71335-9666a1b4c8a1-eaad-4c28-a05e-57f24235231c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9666ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]104Current NDC, 10 package rows20240824_2bd0d4c6-0fde-46f2-bb13-da25d50427df.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9666-07133596660010 TABLET in 1 BOTTLE (71335-9666-0) 10 tablet2023-03-27NoNoHistorical
71335-9666-17133596660115 TABLET in 1 BOTTLE (71335-9666-1) 15 tablet2023-03-27NoNoHistorical
71335-9666-27133596660230 TABLET in 1 BOTTLE (71335-9666-2) 30 tablet2023-03-27NoNoHistorical
71335-9666-37133596660320 TABLET in 1 BOTTLE (71335-9666-3) 20 tablet2023-03-27NoNoHistorical
71335-9666-471335966604100 TABLET in 1 BOTTLE (71335-9666-4) 100 tablet2023-03-27NoNoHistorical
71335-9666-57133596660590 TABLET in 1 BOTTLE (71335-9666-5) 90 tablet2023-03-27NoNoHistorical
71335-9666-67133596660660 TABLET in 1 BOTTLE (71335-9666-6) 60 tablet2023-03-27NoNoHistorical
71335-9666-771335966607120 TABLET in 1 BOTTLE (71335-9666-7) 120 tablet2023-03-27NoNoHistorical
71335-9666-87133596660828 TABLET in 1 BOTTLE (71335-9666-8) 28 tablet2023-03-27NoNoHistorical
71335-9666-9713359666092 TABLET in 1 BOTTLE (71335-9666-9) 2 tablet2023-03-27NoNoHistorical