Guaifenesin and Pseudoephedrine HCl

Product NDC
51660-058
11-digit product format
516600058
Labeler code
51660
Product ID
51660-058_efb49ad2-ac54-4918-9c5a-7228a6dfa21c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
ANDA212542
Marketing category
ANDA
Marketing start
2021-04-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; PSEUDOEPHEDRINE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-058-18516600058181 BLISTER PACK in 1 CARTON (51660-058-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-04-010000-00-00NoNoCurrent