hydroxyzine pamoate

Product NDC
70934-962
11-digit product format
709340962
Labeler code
70934
Product ID
70934-962_f19db111-782b-2cf2-e053-2a95a90a5b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA087479
Marketing category
ANDA
Marketing start
2022-03-24
Marketing end
2026-05-31
Substance
HYDROXYZINE PAMOATE
Active strength
25 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
70934-962-30hydroxyzine pamoate30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-962HYDROXYZINE PAMOATE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20230126_db0d9f72-f5b5-48f7-e053-2995a90af2b6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-962-307093409623030 CAPSULE in 1 BOTTLE, PLASTIC (70934-962-30) 30 capsule2022-03-242026-05-31NoNoCurrent