MECLIZINE HYDROCHLORIDE

Product NDC
35356-901
11-digit product format
353560901
Labeler code
35356
Product ID
35356-901_fd7f6f4d-0acc-4db2-94cd-98d6a9b1c1e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-901-30EA - Each35356-901565401b2-17a7-4098-9534-621b4ab6933012013-08-02
35356-901-60EA - Each35356-901876b3c2d-e4b9-4442-9509-86bf6a9ff18a12013-09-04
35356-901-90EA - Each35356-901cecc10e7-66c1-4762-a910-7d7c7a8a1ab112013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-901MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [QUALITY CARE PRODUCTS LLC]14Legacy NDC20241218_480199c3-9524-475f-897c-5fadab7f9c27.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-901-303535609013030 TABLET in 1 BOTTLE (35356-901-30) 30 tablet2021-04-300000-00-00NoNoCurrent