Anti-Diarrheal

Product NDC
63941-375
11-digit product format
639410375
Labeler code
63941
Product ID
63941-375_c4f62471-381c-498b-984f-eb6e1de3a8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA076497
Marketing category
ANDA
Marketing start
2020-05-05
Marketing end
2028-01-31
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal

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
63941-375-02Anti-Diarrheal2 in 1 CARTONTABLET210
63941-375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET610
63941-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET610
63941-375-08Anti-Diarrheal4 in 1 CARTONTABLET410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [VALU MERCHANDISERS COMPANY]8Current NDC, Legacy NDC, 4 package rows20240824_70a7f827-f5be-454f-99bf-a7fd1037694e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN70a7f827-f5be-454f-99bf-a7fd1037694e10
978010loperamide hydrochloride 2 MG Oral TabletSCD70a7f827-f5be-454f-99bf-a7fd1037694e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-375-02639410375022 BLISTER PACK in 1 CARTON (63941-375-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2020-05-052028-01-31NoNoCurrent
63941-375-08639410375084 BLISTER PACK in 1 CARTON (63941-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2020-05-052028-01-31NoNoCurrent