FDA.reportPublic FDA data

Meclizine HCL 25 mg

Product NDC
68788-7982
Requested package NDC
68788-7982-3
11-digit product format
687887982
Labeler code
68788
Product ID
68788-7982_099baff6-64ac-4c7f-b004-3317c8cea067
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part336
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-28
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine HCL 25 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4201bdc-18b4-4229-a7c0-300c5d5ad8dbAvailable on FDA.report

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
68788-7982-1Meclizine HCL 25 mg10 in 1 BOTTLE, PLASTICTABLET105
68788-7982-3Meclizine HCL 25 mg30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7982-1EA - Each68788-7982ef4aa5be-7142-46d2-8338-f816194ea55812021-09-07
68788-7982-3EA - Each68788-79825156e191-98aa-4a70-93b4-1bce52d9a00b12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7982MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240704_e4201bdc-18b4-4229-a7c0-300c5d5ad8db.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCL 25 mgMECLIZINE HCLPreferred Pharmaceuticals Inc.e4201bdc-18b4-4229-a7c0-300c5d5ad8db2026-06-12WarningsExact identifier
ndc (package): 68788-7982-3
ndc (product): 68788-7982
ndc11 (package): 68788798203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNe4201bdc-18b4-4229-a7c0-300c5d5ad8db5
995632meclizine hydrochloride 25 MG Chewable TabletSCDe4201bdc-18b4-4229-a7c0-300c5d5ad8db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7982-36878879820330 TABLET in 1 BOTTLE, PLASTIC (68788-7982-3) 30 tablet2021-07-280000-00-00NoNoCurrent