Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
24689-123
11-digit product format
246890123
Labeler code
24689
Product ID
24689-123_f17dcc88-303d-4e1f-e053-2a95a90ae08d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
APNAR PHARMA LP
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-123-01EA - Each24689-123cff98a93-5761-46a6-859d-4135d7264d9412023-02-06
24689-123-02EA - Each24689-123e786bae0-22ff-4529-9ed6-4dc23d8f708e12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-123GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET [APNAR PHARMA LP]3Legacy NDC20230108_e22b0c01-390f-2743-e053-2995a90aee29.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-123-012468901230120 TABLET in 1 BOTTLE (24689-123-01) 20 tablet2022-06-300000-00-00NoNoCurrent
24689-123-0224689012302500 TABLET in 1 BOTTLE (24689-123-02) 500 tablet2022-06-300000-00-00NoNoCurrent