Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
68196-073
11-digit product format
681960073
Labeler code
68196
Product ID
68196-073_3cb3ab6b-b6b9-4dbf-a21f-7d5423cc510e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SAM'S WEST INC
Application
NDA021620
Marketing category
NDA
Marketing start
2017-10-31
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1200 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
68196-073-562021-01-29C16284748780-1ba0f9c33-4203-a910-e053-dadaa90a0b85Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-073-56Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE146
68196-073-56Guaifenesin and Dextromethorphan Hydrobromide4 in 1 CARTONTABLET, EXTENDED RELEASE46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-073GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [SAM'S WEST INC]6Legacy NDC, 2 package rows20181107_d5e2b1f7-d610-4600-9479-d2f14bcbc92e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNd5e2b1f7-d610-4600-9479-d2f14bcbc92e6
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDd5e2b1f7-d610-4600-9479-d2f14bcbc92e6
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd5e2b1f7-d610-4600-9479-d2f14bcbc92e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68196-073-566819600735614 in 1 BLISTER PACKHistorical