FDA.reportPublic FDA data

Meclizine HCl

Product NDC
68788-8529
11-digit product format
687888529
Labeler code
68788
Product ID
68788-8529_6f55b7db-ecf9-4dba-b2d7-eafa68f2ca41
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
336
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-06
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 HCl
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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8529-1Meclizine HCl10 in 1 BOTTLETABLET, CHEWABLE103
68788-8529-3Meclizine HCl30 in 1 BOTTLETABLET, CHEWABLE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8529-1EA - Each68788-8529674def47-e92a-4646-92fe-c15cc388774612023-12-05
68788-8529-3EA - Each68788-8529b3740cbc-0707-45be-b3a4-aebeb454186712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8529MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240704_a7f3f32a-0651-4e55-ac51-c85a23352a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNa7f3f32a-0651-4e55-ac51-c85a23352a243
995632meclizine hydrochloride 25 MG Chewable TabletSCDa7f3f32a-0651-4e55-ac51-c85a23352a243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8529-16878885290110 TABLET, CHEWABLE in 1 BOTTLE (68788-8529-1) 2023-10-06NoNoHistorical
68788-8529-36878885290330 TABLET, CHEWABLE in 1 BOTTLE (68788-8529-3) 2023-10-06NoNoHistorical