Anti-Diarrheal

Product NDC
0363-1176
11-digit product format
003631176
Labeler code
0363
Product ID
0363-1176_460acf07-59c8-5b07-e063-6294a90a6021
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREENS
Application
NDA021855
Marketing category
NDA
Marketing start
2018-06-15
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
Anti-Diarrheal
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
0363-1176-08Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127
0363-1176-08Anti-Diarrheal1 in 1 CARTONCAPSULE, LIQUID FILLED17
0363-1176-12Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED27
0363-1176-12Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1176ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [WALGREENS]6Current NDC, Legacy NDC, 4 package rows20221230_50814751-8bee-4768-bf6c-e9da3400090b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN50814751-8bee-4768-bf6c-e9da3400090b7
978006loperamide hydrochloride 2 MG Oral CapsuleSCD50814751-8bee-4768-bf6c-e9da3400090b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1176-08003631176081 BLISTER PACK in 1 CARTON (0363-1176-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2020-03-190000-00-00NoNoCurrent
0363-1176-12003631176122 BLISTER PACK in 1 CARTON (0363-1176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2018-06-150000-00-00NoNoCurrent