FDA.reportPublic FDA data

good neighbor pharmacy Loperamide hydrochloride

Product NDC
46122-111
11-digit product format
461220111
Labeler code
46122
Product ID
46122-111_73240258-ba6f-4c7f-915a-4384ac31ae48
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA091292
Marketing category
ANDA
Marketing start
2012-02-17
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-111-26ML - Milliliter46122-11115ed6240-9be5-4daf-a8a1-6d27e3c554d512013-02-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN0c9a897d-475c-425c-b2fa-5dfd68785e084
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD0c9a897d-475c-425c-b2fa-5dfd68785e084
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY0c9a897d-475c-425c-b2fa-5dfd68785e084
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY0c9a897d-475c-425c-b2fa-5dfd68785e084