FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
0363-9606
11-digit product format
003639606
Labeler code
0363
Product ID
0363-9606_e84eb987-3ed0-42d3-87f4-f14d699ad745
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA211059
Marketing category
ANDA
Marketing start
2022-08-03
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
DIMETHICONE125 mg/1
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 77TI35393C
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
0363-9606-75Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET64
0363-9606-75Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET24
0363-9606-76Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET44
0363-9606-76Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9606LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [WALGREEN CO.]4Current NDC, Legacy NDC, 4 package rows20250112_e22b6c3c-3547-b507-e053-2995a90a714f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNe22b6c3c-3547-b507-e053-2995a90a714f4
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDe22b6c3c-3547-b507-e053-2995a90a714f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9606-75003639606752 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK2 blister pack2022-08-030000-00-00NoNoCurrent
0363-9606-76003639606764 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK4 blister pack2022-08-030000-00-00NoNoCurrent