basic care loperamide hydrochloride

Product NDC
72288-224
11-digit product format
722880224
Labeler code
72288
Product ID
72288-224_732edad8-9a3f-4ce0-a323-c8bffa4acb5f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2021-02-16
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
basic care loperamide hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-224-62basic care loperamide hydrochloride24 in 1 CARTONTABLET, FILM COATED241
72288-224-62basic care loperamide hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-224BASIC CARE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20210224_732edad8-9a3f-4ce0-a323-c8bffa4acb5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN732edad8-9a3f-4ce0-a323-c8bffa4acb5f1
978010loperamide hydrochloride 2 MG Oral TabletSCD732edad8-9a3f-4ce0-a323-c8bffa4acb5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-224-627228802246224 BLISTER PACK in 1 CARTON (72288-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-02-160000-00-00NoNoCurrent