AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE

Product NDC
72288-225
11-digit product format
722880225
Labeler code
72288
Product ID
72288-225_4413b576-5954-4371-bd08-ed57f0a5bc53
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA206548
Marketing category
ANDA
Marketing start
2024-05-15
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
AMAZON 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
72288-225-76AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET62
72288-225-76AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE4 in 1 CARTONTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-225AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) TABLET [AMAZON.COM SERVICES LLC]2Current NDC, 2 package rows20240516_10edd7bc-fc35-abe3-e063-6394a90aeb3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN10edd7bc-fc35-abe3-e063-6394a90aeb3f2
978010loperamide hydrochloride 2 MG Oral TabletSCD10edd7bc-fc35-abe3-e063-6394a90aeb3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-225-76722880225764 BLISTER PACK in 1 CARTON (72288-225-76) / 6 TABLET in 1 BLISTER PACK4 blister pack2024-05-15NoNoCurrent