Rugby Mucus Relief D

Product NDC
0536-1449
11-digit product format
005361449
Labeler code
0536
Product ID
0536-1449_b03262b9-358d-43e9-a55c-0ebe4d7934d0
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin and pseudoephedrine hydrochloride
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA214407
Marketing category
ANDA
Marketing start
2025-04-02
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN
6V9V2RYJ8NPSEUDOEPHEDRINE HYDROCHLORIDE345-78-8PSEUDOEPHEDRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1449-21005361449211 BLISTER PACK in 1 CARTON (0536-1449-21) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-04-02NoNoHistorical
0536-1449-36005361449362 BLISTER PACK in 1 CARTON (0536-1449-36) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-04-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rugby Laboratories Mucus Relief D Drug FactsRugby Laboratories2025-04-02HUMAN OTC DRUG LABEL2