FDA.reportPublic FDA data

Alprazolam

Product NDC
0228-2039
11-digit product format
002282039
Labeler code
0228
Product ID
0228-2039_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
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
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
0228-2039-10Alprazolam100 in 1 BOTTLETABLET10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2039-10EA - Each0228-2039d6d5403e-2123-4017-a966-fb983ea3947b12012-07-24
0228-2039-50EA - Each0228-20397efc6682-2559-4a84-bb12-a57f1ea5dbfc12012-07-24

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
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [MEDSOURCE PHARMACEUTICALS]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2039ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 1 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
197322ALPRAZolam 2 MG Oral TabletPSN1b7f4459-15d8-1051-e054-00144ff8d46c2
197322alprazolam 2 MG Oral TabletSCD1b7f4459-15d8-1051-e054-00144ff8d46c2
308047ALPRAZolam 0.25 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
197321ALPRAZolam 1 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
197322ALPRAZolam 2 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
308047alprazolam 0.25 MG Oral TabletSCD0e6cb388-f5f4-40c7-add2-0d53755538051
197321alprazolam 1 MG Oral TabletSCD0e6cb388-f5f4-40c7-add2-0d53755538051
197322alprazolam 2 MG Oral TabletSCD0e6cb388-f5f4-40c7-add2-0d53755538051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2039-1000228203910100 TABLET in 1 BOTTLE (0228-2039-10) 100 tablet1993-10-010000-00-00NoNoCurrent