FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE

Product NDC
70518-4283
11-digit product format
705184283
Labeler code
70518
Product ID
70518-4283_401a05f7-7d16-93f5-e063-6294a90a3daa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA218122
Marketing category
ANDA
Marketing start
2025-02-10
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
70518-4283-0LOPERAMIDE HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE305
70518-4283-1LOPERAMIDE HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE305
70518-4283-2LOPERAMIDE HYDROCHLORIDE15 in 1 BLISTER PACKCAPSULE155
70518-4283-3LOPERAMIDE HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4283LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]4Current NDC, 4 package rows20250417_3fdfc0e5-56a2-48a0-8ee6-390a194a29f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3fdfc0e5-56a2-48a0-8ee6-390a194a29f35
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fdfc0e5-56a2-48a0-8ee6-390a194a29f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4283-07051842830030 CAPSULE in 1 BLISTER PACK (70518-4283-0) 30 capsule2025-02-10NoNoHistorical
70518-4283-17051842830130 CAPSULE in 1 BLISTER PACK (70518-4283-1) 30 capsule2025-02-14NoNoHistorical
70518-4283-27051842830215 CAPSULE in 1 BLISTER PACK (70518-4283-2) 15 capsule2025-04-01NoNoHistorical
70518-4283-37051842830310 CAPSULE in 1 BLISTER PACK (70518-4283-3) 10 capsule2025-04-07NoNoHistorical