FDA.reportPublic FDA data

Meclizine HCl

Product NDC
33261-748
11-digit product format
332610748
Labeler code
33261
Product ID
33261-748_9c33b6af-82fa-46f5-805d-d2508400e10e
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-07-14
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-748-302020-01-31C16284748780-19d75b9d0-1dd1-f424-e053-dadaa90a57ceMeclizine HCl Caplets USP
33261-748-602020-01-31C16284748780-19d75b9d0-1dd1-f424-e053-dadaa90a57ceMeclizine HCl Caplets USP
33261-748-902020-01-31C16284748780-19d75b9d0-1dd1-f424-e053-dadaa90a57ceMeclizine HCl Caplets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-748-30Meclizine HCl30 in 1 BOTTLE, PLASTICTABLET301
33261-748-60Meclizine HCl60 in 1 BOTTLE, PLASTICTABLET601
33261-748-90Meclizine HCl90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-748-30EA - Each33261-74849d9f35c-4ccd-45c1-95d5-c4dfb44df9fa12015-10-02
33261-748-60EA - Each33261-7487ce574d7-0e9f-40ad-9634-bd300641ff2c12015-10-02
33261-748-90EA - Each33261-748b3a3aee4-b388-4cb8-bcf0-5cff016b7fda12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-748MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_92f98531-e57a-4d41-bbb5-5006edbf276f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN92f98531-e57a-4d41-bbb5-5006edbf276f1
995624meclizine hydrochloride 12.5 MG Oral TabletSCD92f98531-e57a-4d41-bbb5-5006edbf276f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-748-303326107483030 in 1 BOTTLE, PLASTICHistorical
33261-748-603326107486060 in 1 BOTTLE, PLASTICHistorical
33261-748-903326107489090 in 1 BOTTLE, PLASTICHistorical