FDA.reportPublic FDA data

Anti-Diarrheal

Product NDC
41163-375
11-digit product format
411630375
Labeler code
41163
Product ID
41163-375_6954acb7-91c1-491a-85a6-964d4a8d4077
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal
Listing expiration
2027-12-31

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
41163-375-02Anti-Diarrheal2 in 1 CARTONTABLET224
41163-375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
41163-375-08Anti-Diarrheal4 in 1 CARTONTABLET424
41163-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
41163-375-44Anti-Diarrheal3 in 1 CARTONTABLET324
41163-375-44Anti-Diarrheal6 in 1 BLISTER PACKTABLET624

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-375-02EA - Each41163-375060613ec-67d7-4e2a-9994-f13fc8b9626612016-10-06
41163-375-08EA - Each41163-375ec872628-1d13-46b7-bc90-547ba661a52312016-06-14
41163-375-22EA - Each41163-375d26cbdec-e730-459c-abe8-8245827f460812016-12-07
41163-375-44EA - Each41163-375fb41a48c-ad00-4a54-a87d-dbe8aaa4855612016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [SUPERVALU INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]22Current NDC, Legacy NDC, 6 package rows20240724_f16e07f3-0efb-4451-adbb-e427f9abc7ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNf16e07f3-0efb-4451-adbb-e427f9abc7ae24
978010loperamide hydrochloride 2 MG Oral TabletSCDf16e07f3-0efb-4451-adbb-e427f9abc7ae24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-375-02411630375022 BLISTER PACK in 1 CARTON (41163-375-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent
41163-375-08411630375084 BLISTER PACK in 1 CARTON (41163-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent
41163-375-44411630375443 BLISTER PACK in 1 CARTON (41163-375-44) > 6 TABLET in 1 BLISTER PACK3 blister pack2005-05-030000-00-00NoNoCurrent