Loperamide Hydrochloride

Product NDC
71335-2111
11-digit product format
713352111
Labeler code
71335
Product ID
71335-2111_fc76d7e3-6f71-d6c2-e053-6394a90a2f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215001
Marketing category
ANDA
Marketing start
2020-09-25
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
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
71335-2111-0Loperamide Hydrochloride50 in 1 BOTTLECAPSULE50101
71335-2111-1Loperamide Hydrochloride15 in 1 BOTTLECAPSULE15101
71335-2111-2Loperamide Hydrochloride30 in 1 BOTTLECAPSULE30101
71335-2111-3Loperamide Hydrochloride20 in 1 BOTTLECAPSULE20101
71335-2111-4Loperamide Hydrochloride12 in 1 BOTTLECAPSULE12101
71335-2111-5Loperamide Hydrochloride60 in 1 BOTTLECAPSULE60101
71335-2111-6Loperamide Hydrochloride24 in 1 BOTTLECAPSULE24101
71335-2111-7Loperamide Hydrochloride14 in 1 BOTTLECAPSULE14101
71335-2111-8Loperamide Hydrochloride9 in 1 BOTTLECAPSULE9101
71335-2111-9Loperamide Hydrochloride5 in 1 BOTTLECAPSULE5101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2111LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20230528_1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7102
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2111-07133521110050 CAPSULE in 1 BOTTLE (71335-2111-0) 50 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-17133521110115 CAPSULE in 1 BOTTLE (71335-2111-1) 15 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-27133521110230 CAPSULE in 1 BOTTLE (71335-2111-2) 30 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-37133521110320 CAPSULE in 1 BOTTLE (71335-2111-3) 20 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-47133521110412 CAPSULE in 1 BOTTLE (71335-2111-4) 12 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-57133521110560 CAPSULE in 1 BOTTLE (71335-2111-5) 60 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-67133521110624 CAPSULE in 1 BOTTLE (71335-2111-6) 24 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-77133521110714 CAPSULE in 1 BOTTLE (71335-2111-7) 14 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-8713352111089 CAPSULE in 1 BOTTLE (71335-2111-8) 9 capsule2022-06-200000-00-00NoNoCurrent
71335-2111-9713352111095 CAPSULE in 1 BOTTLE (71335-2111-9) 5 capsule2022-06-200000-00-00NoNoCurrent