FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
52959-225
11-digit product format
529590225
Labeler code
52959
Product ID
52959-225_8602b88e-b064-49c4-a224-11829d706003
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA087127
Marketing category
ANDA
Marketing start
1981-06-03
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-225-002019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-072019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-122019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-202019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-212019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-302019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-602019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e
52959-225-902019-11-13C16284748780-197449f38-cb96-f6ea-e053-dbdaa90aa703480076cf-3fc6-4752-985a-9e20f725723e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-225-00Meclizine Hydrochloride100 in 1 BOTTLETABLET1002
52959-225-07Meclizine Hydrochloride7 in 1 BOTTLETABLET72
52959-225-12Meclizine Hydrochloride12 in 1 BOTTLETABLET122
52959-225-20Meclizine Hydrochloride20 in 1 BOTTLETABLET202
52959-225-21Meclizine Hydrochloride21 in 1 BOTTLETABLET212
52959-225-30Meclizine Hydrochloride30 in 1 BOTTLETABLET302
52959-225-60Meclizine Hydrochloride60 in 1 BOTTLETABLET602
52959-225-90Meclizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-225-00EA - Each52959-22508c44597-6424-407f-9aeb-c9441f068cd512012-07-24
52959-225-07EA - Each52959-22551cd2cba-4e41-45f5-9a74-5595e8856c7812012-07-24
52959-225-12EA - Each52959-225c23c127f-e41b-4c80-b050-faeadcf2ef7d12012-07-24
52959-225-20EA - Each52959-2257ecc3221-fdc2-4dee-a6c6-f1d6fae3b5d512012-07-24
52959-225-21EA - Each52959-22526677eda-d145-49cf-a730-da4316eb3ad212012-07-24
52959-225-30EA - Each52959-225fb6840e7-2c5d-4741-a9d9-cce7e9cbd07812012-07-24
52959-225-60EA - Each52959-225df6a6b7d-cd11-4c3e-afcb-5a3c3cbcedd112012-07-24
52959-225-90EA - Each52959-225b26e82ad-f25a-45ff-a316-ea4c1f56446a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-225MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 8 package rows20120120_480076cf-3fc6-4752-985a-9e20f725723e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN480076cf-3fc6-4752-985a-9e20f725723e2
995624meclizine hydrochloride 12.5 MG Oral TabletSCD480076cf-3fc6-4752-985a-9e20f725723e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-225-0052959022500100 in 1 BOTTLEHistorical
52959-225-07529590225077 in 1 BOTTLEHistorical
52959-225-125295902251212 in 1 BOTTLEHistorical
52959-225-205295902252020 in 1 BOTTLEHistorical
52959-225-215295902252121 in 1 BOTTLEHistorical
52959-225-305295902253030 in 1 BOTTLEHistorical
52959-225-605295902256060 in 1 BOTTLEHistorical
52959-225-905295902259090 in 1 BOTTLEHistorical