Loperamide Hydrochloride

Product NDC
70934-546
11-digit product format
709340546
Labeler code
70934
Product ID
70934-546_ac8c6156-56d8-13a8-e053-2a95a90aeadf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA073192
Marketing category
ANDA
Marketing start
2020-02-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-546-152023-01-30C16284748780-1d6a99b39-ae31-a426-e053-dadaa90af4c2ac8c614a-7e2e-1d37-e053-2995a90a8892
70934-546-152022-01-28C16284748780-1d6a99b39-ae31-a426-e053-dadaa90af4c2ac8c614a-7e2e-1d37-e053-2995a90a8892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-546-157093405461515 CAPSULE in 1 BOTTLE, PLASTIC (70934-546-15) 15 capsule2020-02-060000-00-00NoNoCurrent