FDA.reportPublic FDA data

Alprazolam

Product NDC
49884-110
11-digit product format
498840110
Labeler code
49884
Product ID
49884-110_38e94d5e-f7e2-4349-94f2-2fba605f5ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA078088
Marketing category
ANDA
Marketing start
2009-01-09
Substance
ALPRAZOLAM
Active strength
.25 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui485413, 485414, 485415, 485416

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-110-74Alprazolam10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1022
49884-110-74Alprazolam10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-110-74EA - Each49884-1109b444f16-6f0e-48bc-97b0-3f1d79d3cec512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
VANILLININACTIVE INGREDIENTCHI530446XALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-110ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.]20Current NDC, Legacy NDC, 2 package rows20250109_ff1630b4-2044-433c-96bc-0bb4ae8d42a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485413ALPRAZolam 0.25 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485415ALPRAZolam 0.5 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485414ALPRAZolam 1 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485416ALPRAZolam 2 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485413alprazolam 0.25 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485415alprazolam 0.5 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485414alprazolam 1 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485416alprazolam 2 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-110-744988401107410 BLISTER PACK in 1 CARTON (49884-110-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2009-01-090000-00-00NoNoCurrent