Alprazolam

Product NDC
0228-2027
11-digit product format
002282027
Labeler code
0228
Product ID
0228-2027_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
.25 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.25 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
0228-2027-10Alprazolam100 in 1 BOTTLETABLET10022
0228-2027-50Alprazolam500 in 1 BOTTLETABLET50022
0228-2027-96Alprazolam1000 in 1 BOTTLETABLET100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2027-10EA - Each0228-2027a34042c6-7154-41a3-b1e0-9b20f176984e12012-07-24
0228-2027-50EA - Each0228-2027e4326df7-c697-44ce-8f7b-1ef2823af29c12012-07-24
0228-2027-96EA - Each0228-2027b4317345-9fa1-4fc9-82b4-9e242fc2e8be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CHOLINEACTIVE MOIETYN91BDP6H0XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
GELATININACTIVE INGREDIENT2G86QN327LGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
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 [BLENHEIM PHARMACAL, INC.]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [STAT RX USA LLC]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
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [STAT RX USA LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2027ALPRAZOLAM 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 TabletPSN8ca8e0fc-6c3d-48d4-ad04-708182b45350103
308047alprazolam 0.25 MG Oral TabletSCD8ca8e0fc-6c3d-48d4-ad04-708182b45350103
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
308047ALPRAZolam 0.25 MG Oral TabletPSN6224f2c5-8e3c-4bcf-a8c6-a97004d6f43213
308047alprazolam 0.25 MG Oral TabletSCD6224f2c5-8e3c-4bcf-a8c6-a97004d6f43213
308047ALPRAZolam 0.25 MG Oral TabletPSN3364cee6-0a88-47bb-9af8-8e90843de2369
308047alprazolam 0.25 MG Oral TabletSCD3364cee6-0a88-47bb-9af8-8e90843de2369
308047ALPRAZolam 0.25 MG Oral TabletPSNb53734c7-e0e9-40e7-80a7-e9c0e52d27a53
308047ALPRAZolam 0.25 MG Oral TabletPSNb43df4ca-8d28-7b3a-e053-2a95a90aa4d73
308047alprazolam 0.25 MG Oral TabletSCDb43df4ca-8d28-7b3a-e053-2a95a90aa4d73
308047alprazolam 0.25 MG Oral TabletSCDb53734c7-e0e9-40e7-80a7-e9c0e52d27a53
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
308047ALPRAZolam 0.25 MG Oral TabletPSN747d1977-945d-4f51-b493-757c584fee021
308047ALPRAZolam 0.25 MG Oral TabletPSN2717699a-c8b6-4590-937a-cb86eadc52961
308047ALPRAZolam 0.25 MG Oral TabletPSN11bc5c4b-461f-0deb-e054-00144ff8d46c1
308047ALPRAZolam 0.25 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
308047ALPRAZolam 0.25 MG Oral TabletPSNe4164dff-4417-f883-e053-2995a90aae851
197321ALPRAZolam 1 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
197322ALPRAZolam 2 MG Oral TabletPSN0e6cb388-f5f4-40c7-add2-0d53755538051
308047alprazolam 0.25 MG Oral TabletSCDe4164dff-4417-f883-e053-2995a90aae851
308047alprazolam 0.25 MG Oral TabletSCD747d1977-945d-4f51-b493-757c584fee021
308047alprazolam 0.25 MG Oral TabletSCD2717699a-c8b6-4590-937a-cb86eadc52961
308047alprazolam 0.25 MG Oral TabletSCD11bc5c4b-461f-0deb-e054-00144ff8d46c1
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
0228-2027-000022820270077000 TABLET in 1 BAG (0228-2027-00)77000 tablet30-JUL-15Current
0228-2027-1000228202710100 TABLET in 1 BOTTLE (0228-2027-10) 100 tablet1993-10-010000-00-00NoNoCurrent
0228-2027-5000228202750500 TABLET in 1 BOTTLE (0228-2027-50) 500 tablet1993-10-010000-00-00NoNoCurrent
0228-2027-770022820277792304 TABLET in 1 CONTAINER (0228-2027-77)92304 tablet17-JAN-24Current
0228-2027-96002282027961000 TABLET in 1 BOTTLE (0228-2027-96) 1000 tablet1993-10-010000-00-00NoNoCurrent