FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
60687-730
11-digit product format
606870730
Labeler code
60687
Product ID
60687-730_38437b2a-bc23-c6d7-e063-6294a90ac5db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA201451
Marketing category
ANDA
Marketing start
2023-04-20
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666

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
60687-730-01Meclizine Hydrochloride100 in 1 CARTONTABLET1005
60687-730-11Meclizine Hydrochloride1 in 1 BLISTER PACKTABLET15
60687-730-65Meclizine Hydrochloride50 in 1 CARTONTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-730-01EA - Each60687-7307ba0649f-b806-4d61-b520-1de52ec800c212023-05-05
60687-730-11EA - Each60687-730a64d6689-e878-432e-a1d5-fdc48b64d87312023-05-05
60687-730-65EA - Each60687-730d6e70d20-f8af-43f3-8abe-071bcbd91f7b12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-730MECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, 3 package rows20241123_af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine HCl 25 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine hydrochloride 25 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-730-0160687073001100 BLISTER PACK in 1 CARTON (60687-730-01) / 1 TABLET in 1 BLISTER PACK (60687-730-11) 100 blister pack2023-04-20NoNoHistorical
60687-730-11606870730111 in 1 BLISTER PACKHistorical
60687-730-656068707306550 BLISTER PACK in 1 CARTON (60687-730-65) / 1 TABLET in 1 BLISTER PACK (60687-730-11) 50 blister pack2024-02-07NoNoHistorical