FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
72888-130
11-digit product format
728880130
Labeler code
72888
Product ID
72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Ltd.,
Application
ANDA216876
Marketing category
ANDA
Marketing start
2023-01-26
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
Loperamide Hydrochloride
Listing expiration
2027-12-31

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
72888-130-00Loperamide Hydrochloride1000 in 1 BOTTLECAPSULE10003
72888-130-01Loperamide Hydrochloride100 in 1 BOTTLECAPSULE1003
72888-130-05Loperamide Hydrochloride500 in 1 BOTTLECAPSULE5003
72888-130-30Loperamide Hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-130-01EA - Each72888-1303c87ecf6-c374-4a7c-9536-8c1d499f285e12023-06-06
72888-130-05EA - Each72888-130a065447d-c546-4475-8540-2544afa2f5b112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-130LOPERAMIDE HYDROCHLORIDE CAPSULE [ADVAGEN PHARMA LTD.,]1Current NDC, 4 package rows20230403_03c907d5-87f8-47a6-9544-5a24f5272739.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN03c907d5-87f8-47a6-9544-5a24f52727393
978006loperamide hydrochloride 2 MG Oral CapsuleSCD03c907d5-87f8-47a6-9544-5a24f52727393
978006loperamide HCl 2 MG Oral CapsulePSNa2594967-e737-4a23-a710-290ca0e6a2722
978006loperamide HCl 2 MG Oral CapsulePSNf245e8f4-e06e-492e-8c46-af1fce1633fc2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDa2594967-e737-4a23-a710-290ca0e6a2722
978006loperamide hydrochloride 2 MG Oral CapsuleSCDf245e8f4-e06e-492e-8c46-af1fce1633fc2
978006loperamide HCl 2 MG Oral CapsulePSN1e1b762a-800c-b79c-e063-6294a90a99c91
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1e1b762a-800c-b79c-e063-6294a90a99c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-130-00728880130001000 CAPSULE in 1 BOTTLE (72888-130-00) 1000 capsule2023-01-26NoNoCurrent
72888-130-0172888013001100 CAPSULE in 1 BOTTLE (72888-130-01) 100 capsule2023-01-26NoNoCurrent
72888-130-0572888013005500 CAPSULE in 1 BOTTLE (72888-130-05) 500 capsule2023-01-26NoNoCurrent
72888-130-307288801303030 CAPSULE in 1 BOTTLE (72888-130-30) 30 capsule2023-01-26NoNoCurrent