FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
68196-997
11-digit product format
681960997
Labeler code
68196
Product ID
68196-997_298f18eb-cec6-44f9-8e92-a393c5975a65
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin and dextromethorphan hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SAM'S WEST INC
Application
ANDA214781
Marketing category
ANDA
Marketing start
2022-02-16
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-997-562024-01-30C16284748780-11030e365-223f-111a-e063-dadaa90a10e2Guaifenesin and Dextromethorphan HBr

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-997-56Guaifenesin and Dextromethorphan Hydrobromide4 in 1 BLISTER PACKTABLET, EXTENDED RELEASE42
68196-997-56Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-997GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [SAM'S WEST INC]2Legacy NDC, 2 package rows20220302_a9d9d90c-5e9a-4ca6-a667-f04cb1d64c7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNa9d9d90c-5e9a-4ca6-a667-f04cb1d64c7f2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDa9d9d90c-5e9a-4ca6-a667-f04cb1d64c7f2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYa9d9d90c-5e9a-4ca6-a667-f04cb1d64c7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-997-56681960997561 BLISTER PACK in 1 CARTON (68196-997-56) > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-02-160000-00-00NoNoCurrent