Intestinomicina

Product NDC
76864-100
11-digit product format
768640100
Labeler code
76864
Product ID
76864-100_e2877488-3537-cba2-e053-2995a90a6005
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCI, Simethicone
Dosage form
CAPSULE
Route
ORAL
Labeler
Procaps S.A. de C.V.
Application
ANDA214541
Marketing category
ANDA
Marketing start
2018-07-04
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
76864-100-127686401001212 BLISTER PACK in 1 CARTON (76864-100-12) > 1 CAPSULE in 1 BLISTER PACK12 blister pack2022-07-080000-00-00NoNoCurrent