Alprazolam

Product NDC
67253-901
11-digit product format
672530901
Labeler code
67253
Product ID
67253-901_f7f35ad6-705d-4e9e-9ace-6c5eedf6459e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA074174
Marketing category
ANDA
Marketing start
2007-03-28
Marketing end
2022-07-31
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67253-901-10EA - Each67253-9017fc26fe5-7dd8-442e-9676-221271cd7e9912012-07-24
67253-901-11EA - Each67253-9017b9a7d0e-a23e-440f-9d4b-4ebf0418c30c12012-07-24
67253-901-50EA - Each67253-901d35f3158-a22a-40c9-bf22-adc758bbbdab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNcb179805-0e57-4902-82ed-bcfeb6b6452821
308048alprazolam 0.5 MG Oral TabletSCDcb179805-0e57-4902-82ed-bcfeb6b6452821
308048ALPRAZolam 0.5 MG Oral TabletPSN4171e196-8f22-276a-e054-00144ff8d46c2
308048ALPRAZolam 0.5 MG Oral TabletPSN92d435d1-aef5-d28f-e053-2a95a90a9eda2
308048ALPRAZolam 0.5 MG Oral TabletPSN86d4bb01-070f-1d0b-e053-2a91aa0ada9c2
308048alprazolam 0.5 MG Oral TabletSCD4171e196-8f22-276a-e054-00144ff8d46c2
308048alprazolam 0.5 MG Oral TabletSCD92d435d1-aef5-d28f-e053-2a95a90a9eda2
308048alprazolam 0.5 MG Oral TabletSCD86d4bb01-070f-1d0b-e053-2a91aa0ada9c2
308047ALPRAZolam 0.25 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
308047ALPRAZolam 0.25 MG Oral TabletPSN58ada269-01fd-536f-e053-2a91aa0ab5af1
308048ALPRAZolam 0.5 MG Oral TabletPSN175cad46-c9ac-4dd6-a31a-65591b85f8991
308048ALPRAZolam 0.5 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
308048ALPRAZolam 0.5 MG Oral TabletPSN58ada269-01fd-536f-e053-2a91aa0ab5af1
197321ALPRAZolam 1 MG Oral TabletPSN58ada269-01fd-536f-e053-2a91aa0ab5af1
197321ALPRAZolam 1 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
197322ALPRAZolam 2 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
308047alprazolam 0.25 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
308047alprazolam 0.25 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
308048alprazolam 0.5 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
308048alprazolam 0.5 MG Oral TabletSCD175cad46-c9ac-4dd6-a31a-65591b85f8991
308048alprazolam 0.5 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197321alprazolam 1 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
197321alprazolam 1 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197322alprazolam 2 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67253-901-1067253090110100 TABLET in 1 BOTTLE (67253-901-10) 100 tablet2007-03-282022-04-30NoNoCurrent
67253-901-11672530901111000 TABLET in 1 BOTTLE (67253-901-11) 1000 tablet2007-03-282022-07-31NoNoCurrent
67253-901-5067253090150500 TABLET in 1 BOTTLE (67253-901-50) 500 tablet2007-03-282022-02-28NoNoCurrent