FDA.reportPublic FDA data

Alprazolam

Product NDC
65162-810
11-digit product format
651620810
Labeler code
65162
Product ID
65162-810_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078387
Marketing category
ANDA
Marketing start
2009-12-03
Substance
ALPRAZOLAM
Active strength
1 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
ALPRAZOLAM1 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
65162-810-03Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE3015
65162-810-06Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE6015
65162-810-50Alprazolam500 in 1 BOTTLETABLET, EXTENDED RELEASE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-810-06EA - Each65162-810d13eaae1-567f-45e4-b3a8-73e7480506fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC]6
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC]6
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-810ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 3 package rows20240322_259387c1-e374-4bc2-9510-5f7f2c60d1a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSNf8103235-8cc0-4e81-8fe2-1846f91ce4442
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCDf8103235-8cc0-4e81-8fe2-1846f91ce4442
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSYf8103235-8cc0-4e81-8fe2-1846f91ce4442
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-810-036516208100330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-810-03) 2009-12-030000-00-00NoNoCurrent
65162-810-066516208100660 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-810-06) 2009-12-030000-00-00NoNoCurrent
65162-810-5065162081050500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-810-50) 2009-12-030000-00-00NoNoCurrent