VIRTUSSIN DAC

Product NDC
69543-253
11-digit product format
695430253
Labeler code
69543
Product ID
69543-253_36f52bd0-64fc-4330-b625-6fc9bb414a15
Type
HUMAN OTC DRUG
Nonproprietary name
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-31
Marketing end
2022-11-30
Substance
CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC], alpha-Adrenergic Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-253-04ML - Milliliter69543-25348525fd2-8a99-43f8-95e6-f54bff75837912019-02-13
69543-253-16ML - Milliliter69543-253b03fba34-2e05-41b2-b65c-81dc3d9a051312015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-253-0469543025304118 mL in 1 BOTTLE (69543-253-04) 118 ml2019-01-310000-00-00NoNoCurrent