FDA.reportPublic FDA data

Alprazolam

Product NDC
65862-457
11-digit product format
658620457
Labeler code
65862
Product ID
65862-457_f2273fea-bd3b-4ef5-b698-73ba677722e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090871
Marketing category
ANDA
Marketing start
2011-06-07
Substance
ALPRAZOLAM
Active strength
3 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
ALPRAZOLAM3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui433798, 433799, 433800, 433801

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
65862-457-60Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE6016
65862-457-71Alprazolam7000 in 1 BOTTLETABLET, EXTENDED RELEASE700016
65862-457-99Alprazolam1000 in 1 BOTTLETABLET, EXTENDED RELEASE100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-457-60EA - Each65862-457c625550e-074c-4eb4-9ac1-b6d16018e3ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-457ALPRAZOLAM TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 3 package rows20230316_326fa31a-5420-429b-9f7f-170cb38f64bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN326fa31a-5420-429b-9f7f-170cb38f64bd16
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN326fa31a-5420-429b-9f7f-170cb38f64bd16
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN326fa31a-5420-429b-9f7f-170cb38f64bd16
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN326fa31a-5420-429b-9f7f-170cb38f64bd16
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD326fa31a-5420-429b-9f7f-170cb38f64bd16
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD326fa31a-5420-429b-9f7f-170cb38f64bd16
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD326fa31a-5420-429b-9f7f-170cb38f64bd16
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD326fa31a-5420-429b-9f7f-170cb38f64bd16
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY326fa31a-5420-429b-9f7f-170cb38f64bd16
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY326fa31a-5420-429b-9f7f-170cb38f64bd16
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY326fa31a-5420-429b-9f7f-170cb38f64bd16
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY326fa31a-5420-429b-9f7f-170cb38f64bd16
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN5d839a8b-0f45-42bf-acc1-2bd28f948e531
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD5d839a8b-0f45-42bf-acc1-2bd28f948e531
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY5d839a8b-0f45-42bf-acc1-2bd28f948e531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-457-606586204576060 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-457-60) 2011-06-070000-00-00NoNoCurrent
65862-457-71658620457717000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-457-71) 2011-06-070000-00-00NoNoCurrent
65862-457-99658620457991000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-457-99) 2011-06-070000-00-00NoNoCurrent