FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
61919-880
11-digit product format
619190880
Labeler code
61919
Product ID
61919-880_4c49d004-c553-c436-e063-6294a90ad2f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA087479
Marketing category
ANDA
Marketing start
2019-06-03
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253

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
61919-880-15Hydroxyzine Pamoate15 in 1 BOTTLECAPSULE155
61919-880-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE305
61919-880-60Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-880-15EA - Each61919-8804d60a20f-b49f-4e07-98e7-bac27a66b36812019-07-02
61919-880-60EA - Each61919-880c9899d2c-aea9-4a15-9e7e-6d436e5320bc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-880HYDROXYZINE PAMOATE CAPSULE [DIRECT_RX]4Current NDC, Legacy NDC, 3 package rows20240214_8a7084e0-530c-607b-e053-2a95a90a229c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8a7084e0-530c-607b-e053-2a95a90a229c5
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8a7084e0-530c-607b-e053-2a95a90a229c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-880-156191908801515 CAPSULE in 1 BOTTLE (61919-880-15) 15 capsule2019-06-030000-00-00NoNoCurrent
61919-880-306191908803030 CAPSULE in 1 BOTTLE (61919-880-30) 30 capsule2019-06-03NoNoHistorical
61919-880-606191908806060 CAPSULE in 1 BOTTLE (61919-880-60) 60 capsule2019-06-03NoNoHistorical