FDA.reportPublic FDA data

Alprazolam

Product NDC
71335-1894
11-digit product format
713351894
Labeler code
71335
Product ID
71335-1894_7440d6ab-e47a-4f49-8bf3-0c4cb4a44077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203346
Marketing category
ANDA
Marketing start
2015-07-31
Substance
ALPRAZOLAM
Active strength
2 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
ALPRAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYU55MQ3IZY
Rxcui197322

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
71335-1894-1Alprazolam30 in 1 BOTTLETABLET30104
71335-1894-2Alprazolam60 in 1 BOTTLETABLET60104
71335-1894-3Alprazolam90 in 1 BOTTLETABLET90104
71335-1894-4Alprazolam100 in 1 BOTTLETABLET100104
71335-1894-5Alprazolam10 in 1 BOTTLETABLET10104
71335-1894-6Alprazolam120 in 1 BOTTLETABLET120104
71335-1894-7Alprazolam40 in 1 BOTTLETABLET40104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1894-1EA - Each71335-1894d01673ac-74da-4bf9-af08-d4331b7ebab212026-04-20
71335-1894-2EA - Each71335-1894f35d5de1-854b-405b-92a2-e24a7d6e277d12026-04-20
71335-1894-3EA - Each71335-18944b578c8f-9cef-48b6-95c8-45c7567b865012025-03-04
71335-1894-4EA - Each71335-1894578c8cc3-69e0-453f-8691-1400e4b8983a12026-04-20
71335-1894-5EA - Each71335-189424ea33d5-fe9f-4984-b71b-e9674711a92512026-04-20
71335-1894-6EA - Each71335-189478f3f68d-fb16-4347-840e-7c51dcc64b7c12026-04-20
71335-1894-7EA - Each71335-18947e515795-4f0a-4113-9b57-df0e6032dc1312026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1894ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 7 package rows20231025_68d8b8d1-00a4-42c4-a796-90211fee1a6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSN68d8b8d1-00a4-42c4-a796-90211fee1a6d104
197322alprazolam 2 MG Oral TabletSCD68d8b8d1-00a4-42c4-a796-90211fee1a6d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1894-17133518940130 TABLET in 1 BOTTLE (71335-1894-1) 30 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-27133518940260 TABLET in 1 BOTTLE (71335-1894-2) 60 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-37133518940390 TABLET in 1 BOTTLE (71335-1894-3) 90 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-471335189404100 TABLET in 1 BOTTLE (71335-1894-4) 100 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-57133518940510 TABLET in 1 BOTTLE (71335-1894-5) 10 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-671335189406120 TABLET in 1 BOTTLE (71335-1894-6) 120 tablet2021-06-290000-00-00NoNoCurrent
71335-1894-77133518940740 TABLET in 1 BOTTLE (71335-1894-7) 40 tablet2021-06-290000-00-00NoNoCurrent