FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE

Product NDC
50090-7398
11-digit product format
500907398
Labeler code
50090
Product ID
50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-7398-0LOPERAMIDE HYDROCHLORIDE15 in 1 BOTTLECAPSULE155
50090-7398-3LOPERAMIDE HYDROCHLORIDE12 in 1 BOTTLECAPSULE125
50090-7398-4LOPERAMIDE HYDROCHLORIDE30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7398-0EA - Each50090-7398c9f9fc21-7439-4f68-aa69-93965b250cc012024-12-10
50090-7398-3EA - Each50090-7398a935492e-8bb9-41cc-b37c-3f2879721db712024-12-10
50090-7398-4EA - Each50090-7398e618acf9-dd42-464c-bea1-6ded6796c82512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7398LOPERAMIDE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, 3 package rows20241027_d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b5
978006loperamide hydrochloride 2 MG Oral CapsuleSCDd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7398-05009073980015 CAPSULE in 1 BOTTLE (50090-7398-0) 15 capsule2024-10-23NoNoCurrent
50090-7398-35009073980312 CAPSULE in 1 BOTTLE (50090-7398-3) 12 capsule2024-10-23NoNoCurrent
50090-7398-45009073980430 CAPSULE in 1 BOTTLE (50090-7398-4) 30 capsule2024-10-23NoNoCurrent