Loperamide Hydrochloride

Product NDC
33261-344
11-digit product format
332610344
Labeler code
33261
Product ID
33261-344_c11a6272-a3e1-4962-83ca-17bdb3e966c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA073192
Marketing category
ANDA
Marketing start
1993-05-01
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-344-14Loperamide Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE141
33261-344-16Loperamide Hydrochloride16 in 1 BOTTLE, PLASTICCAPSULE161
33261-344-18Loperamide Hydrochloride18 in 1 BOTTLE, PLASTICCAPSULE181
33261-344-20Loperamide Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-344-14EA - Each33261-34448196509-a2d6-48c1-b75e-2ef91686200c12016-09-02
33261-344-16EA - Each33261-344fa558671-7fec-4e8f-a810-68207e653a6a12016-09-02
33261-344-18EA - Each33261-344065c0a7e-1745-4f2f-a880-e84e9dbdf1af12015-10-02
33261-344-20EA - Each33261-3449888c502-1ae6-4562-a624-f3d9185be66412015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-344LOPERAMIDE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140128_a64b9fed-bf27-4e02-876e-72a628a0d8ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNa64b9fed-bf27-4e02-876e-72a628a0d8ef1
978006loperamide hydrochloride 2 MG Oral CapsuleSCDa64b9fed-bf27-4e02-876e-72a628a0d8ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-344-143326103441414 in 1 BOTTLE, PLASTICHistorical
33261-344-163326103441616 in 1 BOTTLE, PLASTICHistorical
33261-344-183326103441818 in 1 BOTTLE, PLASTICHistorical
33261-344-203326103442020 in 1 BOTTLE, PLASTICHistorical