FDA.reportPublic FDA data

Anti-Diarrheal

Product NDC
37808-375
11-digit product format
378080375
Labeler code
37808
Product ID
37808-375_0d66a0ee-7c30-45a1-b3ec-fe96235dfb75
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
H E B
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
37808-375-02Anti-Diarrheal6 in 1 BLISTER PACKTABLET618
37808-375-02Anti-Diarrheal2 in 1 CARTONTABLET218
37808-375-08Anti-Diarrheal4 in 1 CARTONTABLET418
37808-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-375-02EA - Each37808-3757071ace9-2b9d-40cf-ab17-f4f1c930962712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [H E B]16Current NDC, Legacy NDC, 4 package rows20240704_8f7fea50-70cf-4f9f-a655-30371e5b9d9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN8f7fea50-70cf-4f9f-a655-30371e5b9d9f18
978010loperamide hydrochloride 2 MG Oral TabletSCD8f7fea50-70cf-4f9f-a655-30371e5b9d9f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-375-02378080375022 BLISTER PACK in 1 CARTON (37808-375-02) > 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-032022-02-18NoNoCurrent
37808-375-08378080375084 BLISTER PACK in 1 CARTON (37808-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent