Alprazolam

Product NDC
70954-511
11-digit product format
709540511
Labeler code
70954
Product ID
70954-511_18a6f29f-7eb8-4aa2-8121-d554c59da191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA074174
Marketing category
ANDA
Marketing start
2021-05-11
Substance
ALPRAZOLAM
Active strength
2 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
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
70954-511-10Alprazolam100 in 1 BOTTLETABLET1003
70954-511-20Alprazolam500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-511ALPRAZOLAM TABLET [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20230629_38428a1b-718c-49cc-94ae-2e3644ba6256.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN38428a1b-718c-49cc-94ae-2e3644ba62563
308048ALPRAZolam 0.5 MG Oral TabletPSN38428a1b-718c-49cc-94ae-2e3644ba62563
197321ALPRAZolam 1 MG Oral TabletPSN38428a1b-718c-49cc-94ae-2e3644ba62563
197322ALPRAZolam 2 MG Oral TabletPSN38428a1b-718c-49cc-94ae-2e3644ba62563
308047alprazolam 0.25 MG Oral TabletSCD38428a1b-718c-49cc-94ae-2e3644ba62563
308048alprazolam 0.5 MG Oral TabletSCD38428a1b-718c-49cc-94ae-2e3644ba62563
197321alprazolam 1 MG Oral TabletSCD38428a1b-718c-49cc-94ae-2e3644ba62563
197322alprazolam 2 MG Oral TabletSCD38428a1b-718c-49cc-94ae-2e3644ba62563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-511-1070954051110100 TABLET in 1 BOTTLE (70954-511-10) 100 tablet2021-05-110000-00-00NoNoCurrent
70954-511-2070954051120500 TABLET in 1 BOTTLE (70954-511-20) 500 tablet2021-05-110000-00-00NoNoCurrent