hydroxyzine pamoate

Product NDC
71335-1058
11-digit product format
713351058
Labeler code
71335
Product ID
71335-1058_cef1ef27-6965-4aa2-b4f1-9a01e929e937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
2026-05-31
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1058-1hydroxyzine pamoate30 in 1 BOTTLECAPSULE305
71335-1058-2hydroxyzine pamoate60 in 1 BOTTLECAPSULE605
71335-1058-3hydroxyzine pamoate90 in 1 BOTTLECAPSULE905
71335-1058-4hydroxyzine pamoate8 in 1 BOTTLECAPSULE85
71335-1058-5hydroxyzine pamoate20 in 1 BOTTLECAPSULE205
71335-1058-6hydroxyzine pamoate42 in 1 BOTTLECAPSULE425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1058HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20230331_acd58331-ba2e-40ad-a5e6-5f19beb6c4cd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1058-17133510580130 CAPSULE in 1 BOTTLE (71335-1058-1) 30 capsule2019-08-162026-05-31NoNoCurrent
71335-1058-27133510580260 CAPSULE in 1 BOTTLE (71335-1058-2) 60 capsule2021-12-282026-05-31NoNoCurrent
71335-1058-37133510580390 CAPSULE in 1 BOTTLE (71335-1058-3) 90 capsule2019-01-042026-05-31NoNoCurrent
71335-1058-4713351058048 CAPSULE in 1 BOTTLE (71335-1058-4) 8 capsule2021-12-282026-05-31NoNoCurrent
71335-1058-57133510580520 CAPSULE in 1 BOTTLE (71335-1058-5) 20 capsule2019-10-042026-05-31NoNoCurrent
71335-1058-67133510580642 CAPSULE in 1 BOTTLE (71335-1058-6) 42 capsule2019-08-122026-05-31NoNoCurrent