FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
71335-2061
11-digit product format
713352061
Labeler code
71335
Product ID
71335-2061_377e8931-04de-4de7-aca1-bffe36a1a127
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215579
Marketing category
ANDA
Marketing start
2021-12-01
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
71335-2061-0Loperamide Hydrochloride50 in 1 BOTTLE, PLASTICCAPSULE50104
71335-2061-1Loperamide Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE15104
71335-2061-2Loperamide Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE30104
71335-2061-3Loperamide Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE20104
71335-2061-4Loperamide Hydrochloride12 in 1 BOTTLE, PLASTICCAPSULE12104
71335-2061-5Loperamide Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE60104
71335-2061-6Loperamide Hydrochloride24 in 1 BOTTLE, PLASTICCAPSULE24104
71335-2061-7Loperamide Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE14104
71335-2061-8Loperamide Hydrochloride9 in 1 BOTTLE, PLASTICCAPSULE9104
71335-2061-9Loperamide Hydrochloride5 in 1 BOTTLE, PLASTICCAPSULE5104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2061LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240420_691c5dd6-b85d-482b-a8c1-8c4b48b48dc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN691c5dd6-b85d-482b-a8c1-8c4b48b48dc9104
978006loperamide hydrochloride 2 MG Oral CapsuleSCD691c5dd6-b85d-482b-a8c1-8c4b48b48dc9104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2061-07133520610050 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-0) 50 capsule2024-04-030000-00-00NoNoCurrent
71335-2061-17133520610115 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-1) 15 capsule2022-05-100000-00-00NoNoCurrent
71335-2061-27133520610230 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-2) 30 capsule2022-03-170000-00-00NoNoCurrent
71335-2061-37133520610320 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-3) 20 capsule2023-12-110000-00-00NoNoCurrent
71335-2061-47133520610412 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-4) 12 capsule2022-03-100000-00-00NoNoCurrent
71335-2061-57133520610560 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-5) 60 capsule2023-11-270000-00-00NoNoCurrent
71335-2061-67133520610624 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-6) 24 capsule2023-12-050000-00-00NoNoCurrent
71335-2061-77133520610714 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-7) 14 capsule2024-04-030000-00-00NoNoCurrent
71335-2061-8713352061089 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-8) 9 capsule2022-03-150000-00-00NoNoCurrent
71335-2061-9713352061095 CAPSULE in 1 BOTTLE, PLASTIC (71335-2061-9) 5 capsule2024-04-030000-00-00NoNoCurrent