FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
49884-034
11-digit product format
498840034
Labeler code
49884
Product ID
49884-034_d687dbbb-40ef-4614-93e6-c20366f3607d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, 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
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-034-01EA - Each49884-034aab434e3-7d8e-4cfc-a817-b0870dce09b812012-07-24
49884-034-10EA - Each49884-03417944d38-4cec-45c5-8a3e-01550a4a96b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RMECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN480076cf-3fc6-4752-985a-9e20f725723e2
995624meclizine HCl 12.5 MG Oral TabletPSN68c2f8e9-3ba9-4695-af97-4ded925c060a2
995666meclizine HCl 25 MG Oral TabletPSN68c2f8e9-3ba9-4695-af97-4ded925c060a2
995624meclizine hydrochloride 12.5 MG Oral TabletSCD480076cf-3fc6-4752-985a-9e20f725723e2
995624meclizine hydrochloride 12.5 MG Oral TabletSCD68c2f8e9-3ba9-4695-af97-4ded925c060a2
995666meclizine hydrochloride 25 MG Oral TabletSCD68c2f8e9-3ba9-4695-af97-4ded925c060a2
995624meclizine HCl 12.5 MG Oral TabletPSNa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995624meclizine HCl 12.5 MG Oral TabletPSNc65aee98-bddf-4cf7-8d78-17253704b1ab1
995666meclizine HCl 25 MG Oral TabletPSNa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995666meclizine HCl 25 MG Oral TabletPSNc65aee98-bddf-4cf7-8d78-17253704b1ab1
995624meclizine hydrochloride 12.5 MG Oral TabletSCDa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995624meclizine hydrochloride 12.5 MG Oral TabletSCDc65aee98-bddf-4cf7-8d78-17253704b1ab1
995666meclizine hydrochloride 25 MG Oral TabletSCDa7839c4b-6e6e-444f-997e-2dbe28a80eaa1
995666meclizine hydrochloride 25 MG Oral TabletSCDc65aee98-bddf-4cf7-8d78-17253704b1ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-034-0149884003401100 TABLET in 1 BOTTLE (49884-034-01) 100 tablet1981-06-030000-00-00NoNoCurrent
49884-034-10498840034101000 TABLET in 1 BOTTLE (49884-034-10) 1000 tablet1981-06-030000-00-00NoNoCurrent