FDA.reportPublic FDA data

Mucus

Product NDC
46122-417
11-digit product format
461220417
Labeler code
46122
Product ID
46122-417_2c509f3a-4ab3-4e48-8fee-a2ae43bfc657
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
NDA021282
Marketing category
NDA
Marketing start
2017-08-21
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

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
46122-417-742021-01-29C16284748780-1ba0f9c33-0e92-a910-e053-dadaa90a0b85Mucus Extended Release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-417-74MucusExtended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142
46122-417-74MucusExtended Release1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-417-74EA - Each46122-4175c456eef-ca99-41eb-853e-da96323c12c412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-417MUCUS EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [AMERISOURCEBERGEN DRUG CORPORATION]2Legacy NDC, 2 package rows20181115_d55c0e81-c638-480a-b1cc-5216e1e5f940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNd55c0e81-c638-480a-b1cc-5216e1e5f9402
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDd55c0e81-c638-480a-b1cc-5216e1e5f9402
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd55c0e81-c638-480a-b1cc-5216e1e5f9402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46122-417-744612204177414 in 1 BLISTER PACKHistorical