Loperamide Hydrochloride

Product NDC
66267-132
11-digit product format
662670132
Labeler code
66267
Product ID
66267-132_1f93b346-5041-b800-e063-6294a90af72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA073192
Marketing category
ANDA
Marketing start
1993-05-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-132-12Loperamide Hydrochloride12 in 1 BOTTLECAPSULE126
66267-132-15Loperamide Hydrochloride15 in 1 BOTTLECAPSULE156
66267-132-18Loperamide Hydrochloride18 in 1 BOTTLECAPSULE186
66267-132-20Loperamide Hydrochloride20 in 1 BOTTLECAPSULE206
66267-132-60Loperamide Hydrochloride15 in 1 BOTTLECAPSULE156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-132-12EA - Each66267-132fd360286-e6a1-4e45-be31-3b2de61cc8f012016-11-08
66267-132-20EA - Each66267-132ce27e4ac-945d-4dc0-ba34-0f50cf65de7b12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-132LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20240815_3e898141-8d40-49f1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3e898141-8d40-49f1-e054-00144ff88e886
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3e898141-8d40-49f1-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-132-126626701321212 CAPSULE in 1 BOTTLE (66267-132-12) 12 capsule2016-10-100000-00-00NoNoCurrent
66267-132-156626701321515 CAPSULE in 1 BOTTLE (66267-132-15) 15 capsule2016-10-100000-00-00NoNoCurrent
66267-132-186626701321818 CAPSULE in 1 BOTTLE (66267-132-18) 18 capsule2016-10-100000-00-00NoNoCurrent
66267-132-206626701322020 CAPSULE in 1 BOTTLE (66267-132-20) 20 capsule2016-10-100000-00-00NoNoCurrent
66267-132-606626701326015 CAPSULE in 1 BOTTLE (66267-132-60) 15 capsule2017-12-280000-00-00NoNoCurrent