anti-diarrheal

Product NDC
21130-835
11-digit product format
211300835
Labeler code
21130
Product ID
21130-835_323643aa-2d51-0968-e063-6394a90aba7a
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Albertsons Companies
Application
NDA021855
Marketing category
NDA
Marketing start
2025-04-07
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
21130-835-12anti-diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED22
21130-835-12anti-diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-835ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [ALBERTSONS COMPANIES]2Current NDC, 2 package rows20250409_1d4ec76d-ff0d-a55d-e063-6294a90ae22c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN1d4ec76d-ff0d-a55d-e063-6294a90ae22c2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1d4ec76d-ff0d-a55d-e063-6294a90ae22c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-835-12211300835122 BLISTER PACK in 1 CARTON (21130-835-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-04-07NoNoHistorical