Sudafed Sinus Congestion 12 Hour

Product NDC
70518-2654
11-digit product format
705182654
Labeler code
70518
Product ID
70518-2654_d6e2f275-4607-24e6-e053-2995a90a8dd3
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075153
Marketing category
ANDA
Marketing start
2020-03-26
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2654-02022-01-31C16284748780-1d6a99b39-96cf-a426-e053-dadaa90af4c2abafe8b6-2877-49a1-80e4-3077093a1eaa
70518-2654-02022-01-28C16284748780-1d6a99b39-96cf-a426-e053-dadaa90af4c2abafe8b6-2877-49a1-80e4-3077093a1eaa

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2654-0705182654002 BLISTER PACK in 1 CARTON (70518-2654-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-03-260000-00-00NoNoCurrent