FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
50268-399
11-digit product format
502680399
Labeler code
50268
Product ID
50268-399_47e54668-1645-b614-e063-6294a90ad949
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA040156
Marketing category
ANDA
Marketing start
2021-04-14
Substance
HYDROXYZINE PAMOATE
Active strength
50 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 PAMOATE50 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
50268-399-11Hydroxyzine Pamoate1 in 1 BLISTER PACKCAPSULE15
50268-399-50Hydroxyzine Pamoate50 in 1 BOXCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-399-11EA - Each50268-399090faacd-0eb8-453d-bfc0-236068b5d5af12021-05-05
50268-399-50EA - Each50268-39957d39fca-7b83-4340-ac96-34b9a9f5e96112021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-399HYDROXYZINE PAMOATE CAPSULE [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_bff08c15-89b1-00f7-e053-2995a90a2ad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbff08c15-89b1-00f7-e053-2995a90a2ad85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-399-11502680399111 in 1 BLISTER PACKHistorical
50268-399-505026803995050 BLISTER PACK in 1 BOX (50268-399-50) / 1 CAPSULE in 1 BLISTER PACK (50268-399-11) 50 blister pack2021-04-140000-00-00NoNoCurrent