FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
60687-696
11-digit product format
606870696
Labeler code
60687
Product ID
60687-696_276f89cd-550c-fced-e063-6394a90a4181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA088496
Marketing category
ANDA
Marketing start
2023-11-28
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253, 995278

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
60687-696-01Hydroxyzine Pamoate100 in 1 CARTONCAPSULE1005
60687-696-11Hydroxyzine Pamoate1 in 1 BLISTER PACKCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-696-01EA - Each60687-69656dfdecc-992a-4e55-90dd-1d06f76af85e12023-10-16
60687-696-11EA - Each60687-696fa64e9a1-80c4-4311-bf9b-683f8eb1b33b12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-696HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241123_e1a7d95c-e6f6-4a89-90b0-002156e90b41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNe1a7d95c-e6f6-4a89-90b0-002156e90b415
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYe1a7d95c-e6f6-4a89-90b0-002156e90b415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-696-0160687069601100 BLISTER PACK in 1 CARTON (60687-696-01) / 1 CAPSULE in 1 BLISTER PACK (60687-696-11) 100 blister pack2023-11-280000-00-00NoNoCurrent
60687-696-11606870696111 in 1 BLISTER PACKHistorical