FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
71335-1921
11-digit product format
713351921
Labeler code
71335
Product ID
71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1921-0Loperamide Hydrochloride50 in 1 BOTTLE, PLASTICCAPSULE50103
71335-1921-1Loperamide Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE15103
71335-1921-2Loperamide Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE30103
71335-1921-3Loperamide Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE20103
71335-1921-4Loperamide Hydrochloride12 in 1 BOTTLE, PLASTICCAPSULE12103
71335-1921-5Loperamide Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE60103
71335-1921-6Loperamide Hydrochloride24 in 1 BOTTLE, PLASTICCAPSULE24103
71335-1921-7Loperamide Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE14103
71335-1921-8Loperamide Hydrochloride9 in 1 BOTTLE, PLASTICCAPSULE9103
71335-1921-9Loperamide Hydrochloride5 in 1 BOTTLE, PLASTICCAPSULE5103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1921LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20230531_f092b8a5-80b0-40ba-af45-2ac9edaa7704.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1921-07133519210050 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0) 50 capsule2022-05-030000-00-00NoNoCurrent
71335-1921-17133519210115 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1) 15 capsule2021-07-300000-00-00NoNoCurrent
71335-1921-27133519210230 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2) 30 capsule2021-08-300000-00-00NoNoCurrent
71335-1921-37133519210320 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3) 20 capsule2021-08-180000-00-00NoNoCurrent
71335-1921-47133519210412 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4) 12 capsule2021-08-200000-00-00NoNoCurrent
71335-1921-57133519210560 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5) 60 capsule2022-05-030000-00-00NoNoCurrent
71335-1921-67133519210624 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6) 24 capsule2021-07-300000-00-00NoNoCurrent
71335-1921-77133519210714 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7) 14 capsule2022-05-030000-00-00NoNoCurrent
71335-1921-8713351921089 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8) 9 capsule2021-07-260000-00-00NoNoCurrent
71335-1921-9713351921095 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9) 5 capsule2022-02-230000-00-00NoNoCurrent