LOPERAMIDE HYDROCHLORIDE

Product NDC
71335-2571
11-digit product format
713352571
Labeler code
71335
Product ID
71335-2571_483682ad-b007-48de-a8b4-86a5f761be06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA218122
Marketing category
ANDA
Marketing start
2023-09-05
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
LOPERAMIDE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

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
71335-2571-0LOPERAMIDE HYDROCHLORIDE50 in 1 BOTTLECAPSULE501
71335-2571-1LOPERAMIDE HYDROCHLORIDE15 in 1 BOTTLECAPSULE151
71335-2571-2LOPERAMIDE HYDROCHLORIDE30 in 1 BOTTLECAPSULE301
71335-2571-3LOPERAMIDE HYDROCHLORIDE20 in 1 BOTTLECAPSULE201
71335-2571-4LOPERAMIDE HYDROCHLORIDE12 in 1 BOTTLECAPSULE121
71335-2571-5LOPERAMIDE HYDROCHLORIDE60 in 1 BOTTLECAPSULE601
71335-2571-6LOPERAMIDE HYDROCHLORIDE24 in 1 BOTTLECAPSULE241
71335-2571-7LOPERAMIDE HYDROCHLORIDE14 in 1 BOTTLECAPSULE141
71335-2571-8LOPERAMIDE HYDROCHLORIDE9 in 1 BOTTLECAPSULE91
71335-2571-9LOPERAMIDE HYDROCHLORIDE5 in 1 BOTTLECAPSULE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2571LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20250207_86d94804-ad01-4106-8f23-033f3a6bab9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN86d94804-ad01-4106-8f23-033f3a6bab9e1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD86d94804-ad01-4106-8f23-033f3a6bab9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2571-07133525710050 CAPSULE in 1 BOTTLE (71335-2571-0) 50 capsule2025-02-05NoNoHistorical
71335-2571-17133525710115 CAPSULE in 1 BOTTLE (71335-2571-1) 15 capsule2025-02-05NoNoHistorical
71335-2571-27133525710230 CAPSULE in 1 BOTTLE (71335-2571-2) 30 capsule2025-02-05NoNoHistorical
71335-2571-37133525710320 CAPSULE in 1 BOTTLE (71335-2571-3) 20 capsule2025-02-05NoNoHistorical
71335-2571-47133525710412 CAPSULE in 1 BOTTLE (71335-2571-4) 12 capsule2025-02-05NoNoHistorical
71335-2571-57133525710560 CAPSULE in 1 BOTTLE (71335-2571-5) 60 capsule2025-02-05NoNoHistorical
71335-2571-67133525710624 CAPSULE in 1 BOTTLE (71335-2571-6) 24 capsule2025-02-05NoNoHistorical
71335-2571-77133525710714 CAPSULE in 1 BOTTLE (71335-2571-7) 14 capsule2025-02-05NoNoHistorical
71335-2571-8713352571089 CAPSULE in 1 BOTTLE (71335-2571-8) 9 capsule2025-02-05NoNoHistorical
71335-2571-9713352571095 CAPSULE in 1 BOTTLE (71335-2571-9) 5 capsule2025-02-05NoNoHistorical