FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
0378-2100
11-digit product format
003782100
Labeler code
0378
Product ID
0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA072741
Marketing category
ANDA
Marketing start
1991-09-18
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
Loperamide Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

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
0378-2100-01Loperamide Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10014
0378-2100-05Loperamide Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2100-01EA - Each0378-2100ca068534-a324-46e4-bbda-b35d5627375712012-07-24
0378-2100-05EA - Each0378-2100433d8e40-7961-4938-addc-0fe8e6909fbc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]4
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2100LOPERAMIDE HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20240111_72a7ae47-cdf3-4949-b9f8-f29b153f787f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNf092b8a5-80b0-40ba-af45-2ac9edaa7704103
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf092b8a5-80b0-40ba-af45-2ac9edaa7704103
978006loperamide HCl 2 MG Oral CapsulePSNad71d4ab-d293-47a2-8f3f-2c9f42d76e4017
978006loperamide hydrochloride 2 MG Oral CapsuleSCDad71d4ab-d293-47a2-8f3f-2c9f42d76e4017
978006loperamide HCl 2 MG Oral CapsulePSN72a7ae47-cdf3-4949-b9f8-f29b153f787f14
978006loperamide hydrochloride 2 MG Oral CapsuleSCD72a7ae47-cdf3-4949-b9f8-f29b153f787f14
978006loperamide HCl 2 MG Oral CapsulePSN5dd31d61-7081-4895-8321-a77b439d7d2c4
978006loperamide hydrochloride 2 MG Oral CapsuleSCD5dd31d61-7081-4895-8321-a77b439d7d2c4
978006loperamide HCl 2 MG Oral CapsulePSN8b0ac05b-90c1-476b-b001-5801dd21701d3
978006loperamide hydrochloride 2 MG Oral CapsuleSCD8b0ac05b-90c1-476b-b001-5801dd21701d3
978006loperamide HCl 2 MG Oral CapsulePSN6deb0658-c96e-40bd-b3a3-9655a47692702
978006loperamide HCl 2 MG Oral CapsulePSNa66d2f97-8d22-482d-b18b-f58f1d882f422
978006loperamide HCl 2 MG Oral CapsulePSN59a44282-30f2-103b-e053-2a91aa0a643a2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDa66d2f97-8d22-482d-b18b-f58f1d882f422
978006loperamide hydrochloride 2 MG Oral CapsuleSCD6deb0658-c96e-40bd-b3a3-9655a47692702
978006loperamide hydrochloride 2 MG Oral CapsuleSCD59a44282-30f2-103b-e053-2a91aa0a643a2
978006loperamide HCl 2 MG Oral CapsulePSNc5322892-cb14-4a25-9b42-e62e491bc1011
978006loperamide HCl 2 MG Oral CapsulePSN3fc80822-6256-4937-e054-00144ff8d46c1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fc80822-6256-4937-e054-00144ff8d46c1
978006loperamide hydrochloride 2 MG Oral CapsuleSCDc5322892-cb14-4a25-9b42-e62e491bc1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-2100-0100378210001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01) 100 capsule1991-09-180000-00-00NoNoCurrent
0378-2100-0500378210005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05) 500 capsule1991-09-180000-00-00NoNoCurrent