Guaifenesin

Product NDC
63868-390
11-digit product format
638680390
Labeler code
63868
Product ID
63868-390_469be0ad-f587-4e64-b556-6e102ec5abf1
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
NDA021282
Marketing category
NDA
Marketing start
2017-10-15
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
63868-390-142021-01-29C16284748780-1ba0f9c33-0e8c-a910-e053-dadaa90a0b85Guaifenesin Extended-Release Tablets 1200 mg
63868-390-282021-01-29C16284748780-1ba0f9c33-0e8c-a910-e053-dadaa90a0b85Guaifenesin Extended-Release Tablets 1200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-390-14GuaifenesinExtended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
63868-390-14GuaifenesinExtended Release1 in 1 CARTONTABLET, EXTENDED RELEASE13
63868-390-28GuaifenesinExtended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
63868-390-28GuaifenesinExtended Release2 in 1 CARTONTABLET, EXTENDED RELEASE23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-390-14EA - Each63868-3906604ca21-ca84-4f40-8c94-78d65c88014012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-390GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]3Legacy NDC, 4 package rows20181102_fa05cfe6-5019-4c1b-8fe0-c2c0e278e89e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNfa05cfe6-5019-4c1b-8fe0-c2c0e278e89e3
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDfa05cfe6-5019-4c1b-8fe0-c2c0e278e89e3
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYfa05cfe6-5019-4c1b-8fe0-c2c0e278e89e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-390-146386803901414 in 1 BLISTER PACKHistorical
63868-390-286386803902814 in 1 BLISTER PACKHistorical