Alprazolam

Product NDC
63187-518
11-digit product format
631870518
Labeler code
63187
Product ID
63187-518_b2f8ddeb-2879-48e7-a026-1de3bc87610d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090871
Marketing category
ANDA
Marketing start
2011-06-07
Substance
ALPRAZOLAM
Active strength
.5 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.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui433798

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
63187-518-30Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE303
63187-518-60Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE603
63187-518-90Alprazolam90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-518ALPRAZOLAM TABLET, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210114_969acb29-3b5c-47ed-8f7d-a960a24e72e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN969acb29-3b5c-47ed-8f7d-a960a24e72e33
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD969acb29-3b5c-47ed-8f7d-a960a24e72e33
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY969acb29-3b5c-47ed-8f7d-a960a24e72e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-518-306318705183030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-30) 2018-12-010000-00-00NoNoCurrent
63187-518-606318705186060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-60) 2018-12-010000-00-00NoNoCurrent
63187-518-906318705189090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-518-90) 2018-12-010000-00-00NoNoCurrent