Alprazolam ODT C-IV

Product NDC
72189-637
11-digit product format
721890637
Labeler code
72189
Product ID
72189-637_4d3aab18-54e7-cb65-e063-6394a90a9b26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam ODT C-IV
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078088
Marketing category
ANDA
Marketing start
2025-08-22
Substance
ALPRAZOLAM
Active strength
.5 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 ODT C-IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui485415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-637-02Alprazolam ODT C-IV2 in 1 CARTONTABLET, ORALLY DISINTEGRATING22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-637-02EA - Each72189-6374d51c7b1-9537-4780-8193-238944ff3c5b12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485415ALPRAZolam 0.5 MG Disintegrating Oral TabletPSN3cf95203-c8b4-9f06-e063-6394a90abc9c2
485415alprazolam 0.5 MG Disintegrating Oral TabletSCD3cf95203-c8b4-9f06-e063-6394a90abc9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-637-02721890637022 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-637-02) 2025-08-22NoNoHistorical