Anti-Diarrheal

Product NDC
55910-375
11-digit product format
559100375
Labeler code
55910
Product ID
55910-375_984bd6b4-1cc2-4f07-ad8f-d9e5ca443ebd
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
ANDA076497
Marketing category
ANDA
Marketing start
2024-01-12
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
Rxcui978010

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
55910-375-02Anti-Diarrheal2 in 1 CARTONTABLET24
55910-375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET64
55910-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET64
55910-375-08Anti-Diarrheal4 in 1 CARTONTABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [DOLGENCORP, LLC]3Current NDC, 4 package rows20250206_78814c22-5be2-45ee-b0be-977844746fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN78814c22-5be2-45ee-b0be-977844746fcc4
978010loperamide hydrochloride 2 MG Oral TabletSCD78814c22-5be2-45ee-b0be-977844746fcc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-375-02559100375022 BLISTER PACK in 1 CARTON (55910-375-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2024-01-12NoNoCurrent
55910-375-08559100375084 BLISTER PACK in 1 CARTON (55910-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2024-01-12NoNoCurrent