FDA.reportPublic FDA data

Meclizine HCL 12.5 mg

Product NDC
71205-762
11-digit product format
712050762
Labeler code
71205
Product ID
71205-762_68e003ca-181b-4fe8-aedd-dc7f8efd306c
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL 12.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine HCL 12.5 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-762-10Meclizine HCL 12.5 mg10 in 1 BOTTLE, PLASTICTABLET104
71205-762-30Meclizine HCL 12.5 mg30 in 1 BOTTLE, PLASTICTABLET304
71205-762-60Meclizine HCL 12.5 mg60 in 1 BOTTLE, PLASTICTABLET604
71205-762-90Meclizine HCL 12.5 mg90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-762MECLIZINE HCL 12.5 MG TABLET [PROFICIENT RX LP]2Current NDC, 4 package rows20240125_3ffa63f2-ea06-4be0-9f59-162c2a9604fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN3ffa63f2-ea06-4be0-9f59-162c2a9604fc4
995624meclizine hydrochloride 12.5 MG Oral TabletSCD3ffa63f2-ea06-4be0-9f59-162c2a9604fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-762-107120507621010 TABLET in 1 BOTTLE, PLASTIC (71205-762-10) 10 tablet2026-04-10NoNoCurrent
71205-762-307120507623030 TABLET in 1 BOTTLE, PLASTIC (71205-762-30) 30 tablet2023-02-09NoNoCurrent
71205-762-607120507626060 TABLET in 1 BOTTLE, PLASTIC (71205-762-60) 60 tablet2023-02-09NoNoCurrent
71205-762-907120507629090 TABLET in 1 BOTTLE, PLASTIC (71205-762-90) 90 tablet2023-02-09NoNoCurrent