FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
79903-223
11-digit product format
799030223
Labeler code
79903
Product ID
79903-223_d5cdb88f-1858-4e14-a988-2db6865255c5
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
WALMART INC.
Application
ANDA211059
Marketing category
ANDA
Marketing start
2024-02-17
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125; 2 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
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 and Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE125 mg/1
DIMETHICONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C, 92RU3N3Y1O
Rxcui978001

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
79903-223-12Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23
79903-223-12Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
79903-223-24Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
79903-223-24Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-223LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [WALMART INC.]3Current NDC, 4 package rows20250112_12940c3b-dc58-31fb-e063-6294a90ae880.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN12940c3b-dc58-31fb-e063-6294a90ae8803
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD12940c3b-dc58-31fb-e063-6294a90ae8803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-223-12799030223122 BLISTER PACK in 1 CARTON (79903-223-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2024-02-17NoNoHistorical
79903-223-24799030223244 BLISTER PACK in 1 CARTON (79903-223-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2024-02-17NoNoHistorical