Alprazolam

Product NDC
82868-061
11-digit product format
828680061
Labeler code
82868
Product ID
82868-061_46dccd28-a51d-7582-e063-6294a90ad34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA203346
Marketing category
ANDA
Marketing start
2024-08-01
Substance
ALPRAZOLAM
Active strength
.25 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.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui308047

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
82868-061-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-061ALPRAZOLAM TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20241024_25174ee5-a86e-ab97-e063-6394a90acd87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN25174ee5-a86e-ab97-e063-6394a90acd872
308047alprazolam 0.25 MG Oral TabletSCD25174ee5-a86e-ab97-e063-6394a90acd872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-061-308286800613030 TABLET in 1 BOTTLE, PLASTIC (82868-061-30) 30 tablet2024-08-01NoNoHistorical