Hydroxyzine Pamoate

Product NDC
71335-1923
11-digit product format
713351923
Labeler code
71335
Product ID
71335-1923_7142bcf3-e30c-41ec-824a-a9f4f0041046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-06-15
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-1923_7142bcf3-e30c-41ec-824a-a9f4f0041046
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Generic name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Marketing start
1996-06-15
Marketing category
ANDA
Application number
ANDA040156
Pharmacologic classes
Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiM20215MUFR
Rxcui995278
Spl Set Id4ea3336a-2cc8-4e43-bc55-455fca67976e
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1923-17133519230130 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-1) 30 capsule2022-01-200000-00-00NoNoCurrent
71335-1923-27133519230260 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-2) 60 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-37133519230390 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-3) 90 capsule2022-01-110000-00-00NoNoCurrent
71335-1923-4713351923048 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-4) 8 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-57133519230520 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-5) 20 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-67133519230642 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-6) 42 capsule2022-02-140000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx onlyBryant Ranch Prepack2023-11-27HUMAN PRESCRIPTION DRUG LABEL103