MECLIZINE

Product NDC
43063-804
11-digit product format
430630804
Labeler code
43063
Product ID
43063-804_2fb4b0a4-ecff-437f-e063-6394a90a2d5f
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-804-01MECLIZINE100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10014
43063-804-06MECLIZINE6 in 1 BOTTLE, PLASTICTABLET, CHEWABLE614
43063-804-12MECLIZINE12 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1214
43063-804-20MECLIZINE20 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2014
43063-804-30MECLIZINE30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-804-01EA - Each43063-804f0e47f6b-3f09-43d8-8ce2-771a1846c26812018-03-08
43063-804-12EA - Each43063-804939a1d6b-47bf-4263-a894-09879823b0a312018-01-12
43063-804-20EA - Each43063-8045504be70-097b-4721-ba3c-f1d227ff8cb612018-02-20
43063-804-30EA - Each43063-80416228db3-bdfd-44a7-886f-1f0caf69e7b712018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-804MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 5 package rows20250313_cf79ac74-017e-4fb4-85d3-4ea944080e89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine hydrochloride 25 MG Chewable TabletSCDcf79ac74-017e-4fb4-85d3-4ea944080e8914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-804-0143063080401100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-01) 2018-02-182027-11-30NoNoCurrent
43063-804-06430630804066 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-06) 2018-07-232027-11-30NoNoCurrent
43063-804-124306308041212 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-12) 2018-02-012027-11-30NoNoCurrent
43063-804-204306308042020 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-20) 2018-02-012027-11-30NoNoCurrent
43063-804-304306308043030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-30) 2018-02-012027-11-30NoNoCurrent