FDA.reportPublic FDA data

Alprazolam

Product NDC
0228-2029
11-digit product format
002282029
Labeler code
0228
Product ID
0228-2029_9cf12473-8eb9-4248-bfce-76eef6b82bfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074342
Marketing category
ANDA
Marketing start
1993-10-01
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
Rxcui197321, 197322, 308047, 308048

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
0228-2029-10Alprazolam100 in 1 BOTTLETABLET10022
0228-2029-50Alprazolam500 in 1 BOTTLETABLET50022
0228-2029-96Alprazolam1000 in 1 BOTTLETABLET100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2029-10EA - Each0228-202941c8fc34-5351-47c2-ba67-c780dbd2680412012-07-24
0228-2029-50EA - Each0228-2029c7f9070a-027c-4c19-aa84-b4ace2a3074012012-07-24
0228-2029-96EA - Each0228-202980f4a52d-0cbe-4dae-8b33-26e88a649e0512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2029ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 3 package rows20250116_a23063c0-099a-4256-b95f-3a857bbf704b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNa23063c0-099a-4256-b95f-3a857bbf704b22
308048ALPRAZolam 0.5 MG Oral TabletPSNa23063c0-099a-4256-b95f-3a857bbf704b22
197321ALPRAZolam 1 MG Oral TabletPSNa23063c0-099a-4256-b95f-3a857bbf704b22
197322ALPRAZolam 2 MG Oral TabletPSNa23063c0-099a-4256-b95f-3a857bbf704b22
308047alprazolam 0.25 MG Oral TabletSCDa23063c0-099a-4256-b95f-3a857bbf704b22
308048alprazolam 0.5 MG Oral TabletSCDa23063c0-099a-4256-b95f-3a857bbf704b22
197321alprazolam 1 MG Oral TabletSCDa23063c0-099a-4256-b95f-3a857bbf704b22
197322alprazolam 2 MG Oral TabletSCDa23063c0-099a-4256-b95f-3a857bbf704b22
308048ALPRAZolam 0.5 MG Oral TabletPSN5040e1ed-32d6-4757-a0ee-b8240f3e7cf521
308048alprazolam 0.5 MG Oral TabletSCD5040e1ed-32d6-4757-a0ee-b8240f3e7cf521
308048ALPRAZolam 0.5 MG Oral TabletPSN8ef75d22-4a7c-48d5-a532-5a43b8593e7c12
308048alprazolam 0.5 MG Oral TabletSCD8ef75d22-4a7c-48d5-a532-5a43b8593e7c12
308048ALPRAZolam 0.5 MG Oral TabletPSNb39e2bc8-b68f-0f4e-e053-2995a90a00fd6
308048ALPRAZolam 0.5 MG Oral TabletPSN25781f50-d309-4c4f-9e21-c019e068d1016
308048alprazolam 0.5 MG Oral TabletSCDb39e2bc8-b68f-0f4e-e053-2995a90a00fd6
308048alprazolam 0.5 MG Oral TabletSCD25781f50-d309-4c4f-9e21-c019e068d1016
308048ALPRAZolam 0.5 MG Oral TabletPSNaaf7979c-168a-0da2-e053-2995a90a4d123
308048alprazolam 0.5 MG Oral TabletSCDaaf7979c-168a-0da2-e053-2995a90a4d123
308047ALPRAZolam 0.25 MG Oral TabletPSN3c367c14-bcc3-4c02-baa1-d6a0f39986972
308048ALPRAZolam 0.5 MG Oral TabletPSN3c367c14-bcc3-4c02-baa1-d6a0f39986972
308047alprazolam 0.25 MG Oral TabletSCD3c367c14-bcc3-4c02-baa1-d6a0f39986972
308048alprazolam 0.5 MG Oral TabletSCD3c367c14-bcc3-4c02-baa1-d6a0f39986972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2029-1000228202910100 TABLET in 1 BOTTLE (0228-2029-10) 100 tablet1993-10-010000-00-00NoNoCurrent
0228-2029-5000228202950500 TABLET in 1 BOTTLE (0228-2029-50) 500 tablet1993-10-010000-00-00NoNoCurrent
0228-2029-96002282029961000 TABLET in 1 BOTTLE (0228-2029-96) 1000 tablet1993-10-010000-00-00NoNoCurrent