FDA.reportPublic FDA data

Anti-Diarrheal

Product NDC
0363-0375
11-digit product format
003630375
Labeler code
0363
Product ID
0363-0375_5cb15e58-9b8c-4663-9f8e-83894f89aa45
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
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
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
0363-0375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
0363-0375-02Anti-Diarrheal2 in 1 CARTONTABLET224
0363-0375-08Anti-Diarrheal4 in 1 CARTONTABLET424
0363-0375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
0363-0375-45Anti-Diarrheal1 in 1 CARTONTABLET124
0363-0375-45Anti-Diarrheal6 in 1 BLISTER PACKTABLET624

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0375-02EA - Each0363-0375a96dbf42-c307-4799-9bf3-c946c62c1f5812015-06-09
0363-0375-06EA - Each0363-03758679441f-428a-4cac-b79d-ecbfeb8d15ac12015-06-09
0363-0375-07EA - Each0363-03759c4412b7-04b6-41a2-8b62-9518358ddd7312019-12-10
0363-0375-08EA - Each0363-03758634d2c1-bd2f-422c-a840-2ef9520c180b12012-07-24
0363-0375-22EA - Each0363-03751ef71869-e395-4999-9287-14ca3f372a9d12012-07-24
0363-0375-45EA - Each0363-0375e5ec5b70-3a25-4539-9cf2-2ff440e7bebe12012-07-24
0363-0375-46EA - Each0363-0375b22a11bb-573d-444a-82ab-9751080c6d7c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN CO.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [WALGREEN COMPANY]23Current NDC, Legacy NDC, 6 package rows20241009_31f9b652-e9c9-46ed-a46c-22d30ad11004.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN31f9b652-e9c9-46ed-a46c-22d30ad1100424
978010loperamide hydrochloride 2 MG Oral TabletSCD31f9b652-e9c9-46ed-a46c-22d30ad1100424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0375-02003630375022 BLISTER PACK in 1 CARTON (0363-0375-02) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent
0363-0375-08003630375084 BLISTER PACK in 1 CARTON (0363-0375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent
0363-0375-45003630375451 BLISTER PACK in 1 CARTON (0363-0375-45) / 6 TABLET in 1 BLISTER PACK1 blister pack2005-05-030000-00-00NoNoCurrent