loperamide hydrochloride and simethicone

Product NDC
69842-807
11-digit product format
698420807
Labeler code
69842
Product ID
69842-807_005cc87d-19ba-4fe3-aa68-a460e81b7d3a
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-08
Marketing end
0000-00-00
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-807-536984208075312 BLISTER PACK in 1 CARTON (69842-807-53) > 1 TABLET in 1 BLISTER PACK12 blister pack2018-10-080000-00-00NoNoCurrent
69842-807-65698420807651 BOTTLE in 1 CARTON (69842-807-65) > 30 TABLET in 1 BOTTLE1 bottle2018-10-160000-00-00NoNoCurrent