Pentrexcilina Day time

Product NDC
69729-137
11-digit product format
697290137
Labeler code
69729
Product ID
69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
OPMX LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2024-11-15
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pentrexcilina Day time
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-137-14Pentrexcilina Day time14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-137PENTREXCILINA DAY TIME (CETIRIZINE HYDROCHLORIDE) TABLET [OPMX LLC]1Current NDC, 1 package rows20241121_26f56cb7-be58-a0c2-e063-6294a90a15fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN26f56cb7-be58-a0c2-e063-6294a90a15fa1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD26f56cb7-be58-a0c2-e063-6294a90a15fa1
1014678cetirizine HCl 10 MG Oral TabletSY26f56cb7-be58-a0c2-e063-6294a90a15fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-137-146972901371414 TABLET in 1 BOTTLE (69729-137-14) 14 tablet2024-11-15NoNoCurrent