ANTI-DIARRHEAL

Product NDC
80136-851
11-digit product format
801360851
Labeler code
80136
Product ID
80136-851_f1172e57-0b18-d64f-e053-2a95a90a44db
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Northeast Pharma
Application
NDA021855
Marketing category
NDA
Marketing start
2021-05-21
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
80136-851-42ANTI-DIARRHEAL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
80136-851-42ANTI-DIARRHEAL2 in 1 CARTONCAPSULE, LIQUID FILLED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-851ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [NORTHEAST PHARMA]2Current NDC, Legacy NDC, 2 package rows20230101_c2db4155-68d4-71be-e053-2a95a90a7f35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNc2db4155-68d4-71be-e053-2a95a90a7f352
978006loperamide hydrochloride 2 MG Oral CapsuleSCDc2db4155-68d4-71be-e053-2a95a90a7f352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80136-851-42801360851422 BLISTER PACK in 1 CARTON (80136-851-42) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-05-210000-00-00NoNoCurrent