Alprazolam

Product NDC
43063-609
11-digit product format
430630609
Labeler code
43063
Product ID
43063-609_2f3aacb7-ebbb-e49e-e063-6394a90a9176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197321

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
43063-609-30Alprazolam30 in 1 BOTTLE, PLASTICTABLET3026
43063-609-40Alprazolam40 in 1 BOTTLE, PLASTICTABLET4026
43063-609-60Alprazolam60 in 1 BOTTLE, PLASTICTABLET6026
43063-609-90Alprazolam90 in 1 BOTTLE, PLASTICTABLET9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-609-30EA - Each43063-6093a706bb2-c28e-4614-8e14-345ce3a88cde12016-01-13
43063-609-40EA - Each43063-6093916890a-b976-48fc-b0ab-b38ab572301512016-01-13
43063-609-60EA - Each43063-60922d3e70d-c7f0-42d0-b9ca-5df81f3a71ae12015-11-12
43063-609-90EA - Each43063-6099ea252c8-5224-4c1a-8a39-5cfba300808212015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-609ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 4 package rows20250303_0ffcdbab-17e4-4395-8155-5b6ad00be6c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN0ffcdbab-17e4-4395-8155-5b6ad00be6c226
197321alprazolam 1 MG Oral TabletSCD0ffcdbab-17e4-4395-8155-5b6ad00be6c226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-609-304306306093030 TABLET in 1 BOTTLE, PLASTIC (43063-609-30) 30 tablet2015-10-062027-03-19NoNoCurrent
43063-609-404306306094040 TABLET in 1 BOTTLE, PLASTIC (43063-609-40) 40 tablet2015-10-192027-03-19NoNoCurrent
43063-609-604306306096060 TABLET in 1 BOTTLE, PLASTIC (43063-609-60) 60 tablet2015-09-032027-03-19NoNoCurrent
43063-609-904306306099090 TABLET in 1 BOTTLE, PLASTIC (43063-609-90) 90 tablet2015-09-032027-03-19NoNoCurrent