Alprazolam

Product NDC
67253-900
11-digit product format
672530900
Labeler code
67253
Product ID
67253-900_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
0 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67253-900-09EA - Each67253-9009e9cfc8d-b8d1-465d-b97c-a28a46d1708312012-07-24
67253-900-10EA - Each67253-900c34201c0-bd0c-4deb-b9db-f91da75c602c12012-07-24
67253-900-11EA - Each67253-900cf64543a-c431-45d8-ba08-e6e8cea8fc9412012-07-24
67253-900-50EA - Each67253-9001420bc55-72cf-49fb-9e92-f44bcd78e37812012-07-24

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNa1072746-7662-4b15-b1d5-9e5f9421282c3
308047alprazolam 0.25 MG Oral TabletSCDa1072746-7662-4b15-b1d5-9e5f9421282c3
308047ALPRAZolam 0.25 MG Oral TabletPSN11f5cd79-ddac-3e16-e054-00144ff8d46c2
308047alprazolam 0.25 MG Oral TabletSCD11f5cd79-ddac-3e16-e054-00144ff8d46c2
308047ALPRAZolam 0.25 MG Oral TabletPSN247ed237-e0b7-4de4-8e6a-f1d9d9b917d71
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 TabletPSN58ada269-01fd-536f-e053-2a91aa0ab5af1
308048ALPRAZolam 0.5 MG Oral TabletPSNfd3d0e37-470d-4216-8070-24a206930eac1
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 TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
308047alprazolam 0.25 MG Oral TabletSCD247ed237-e0b7-4de4-8e6a-f1d9d9b917d71
308047alprazolam 0.25 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
308048alprazolam 0.5 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
308048alprazolam 0.5 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197321alprazolam 1 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1
197321alprazolam 1 MG Oral TabletSCD58ada269-01fd-536f-e053-2a91aa0ab5af1
197322alprazolam 2 MG Oral TabletSCDfd3d0e37-470d-4216-8070-24a206930eac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67253-900-096725309000990 TABLET in 1 BOTTLE (67253-900-09) 90 tablet2007-03-282022-03-31NoNoCurrent
67253-900-1067253090010100 TABLET in 1 BOTTLE (67253-900-10) 100 tablet2007-03-282022-07-31NoNoCurrent
67253-900-11672530900111000 TABLET in 1 BOTTLE (67253-900-11) 1000 tablet2007-03-282022-03-31NoNoCurrent
67253-900-5067253090050500 TABLET in 1 BOTTLE (67253-900-50) 500 tablet2007-03-282022-03-31NoNoCurrent