Guaifenesin

Product NDC
68196-072
11-digit product format
681960072
Labeler code
68196
Product ID
68196-072_4c4c6cdb-d31b-4f1c-abc0-678278a1f078
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SAM'S WEST INC
Application
NDA021282
Marketing category
NDA
Marketing start
2017-10-31
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
1200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-072-562021-01-29C16284748780-1ba0f9c33-5692-a910-e053-dadaa90a0b85GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-072-56Guaifenesin Extended Release4 in 1 CARTONTABLET, EXTENDED RELEASE45
68196-072-56Guaifenesin Extended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-072GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [SAM'S WEST INC]5Legacy NDC, 2 package rows20181214_f363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNf363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda5
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDf363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda5
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68196-072-56681960072564 in 1 CARTONHistorical