FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
0440-1736
11-digit product format
004401736
Labeler code
0440
Product ID
0440-1736_52fa42cf-efc4-4a01-ab61-2376c59799bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA087128
Marketing category
ANDA
Marketing start
1981-06-03
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-1736-082020-01-31C16284748780-19d75b9d0-8401-f424-e053-dadaa90a57ceMECLIZINE FOR PAR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1736-08Meclizine Hydrochloride08 in 1 BOTTLE, PLASTICTABLET081

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1736-08EA - Each0440-1736b2935dc9-c5f8-41cb-836a-30c5f5e101bf12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1736MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20130911_020b7dd4-c270-4046-97f2-c646ce067168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN020b7dd4-c270-4046-97f2-c646ce0671681
995666meclizine hydrochloride 25 MG Oral TabletSCD020b7dd4-c270-4046-97f2-c646ce0671681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1736-080044017360808 in 1 BOTTLE, PLASTICHistorical