FDA.reportPublic FDA data

GUAIFENESIN

Product NDC
51660-070
11-digit product format
516600070
Labeler code
51660
Product ID
51660-070_66f1ce00-b45d-4ce2-8f38-c58eac2f795e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC
Application
NDA021282
Marketing category
NDA
Marketing start
2018-01-08
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 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
51660-070-212024-01-30C16284748780-11030e365-67fe-111a-e063-dadaa90a10e2GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 mg
51660-070-412024-01-30C16284748780-11030e365-67fe-111a-e063-dadaa90a10e2GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-070-21GUAIFENESIN20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE205
51660-070-21GUAIFENESIN1 in 1 CARTONTABLET, EXTENDED RELEASE15
51660-070-41GUAIFENESIN2 in 1 CARTONTABLET, EXTENDED RELEASE25
51660-070-41GUAIFENESIN20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-070-21EA - Each51660-070def0f666-9eb5-4439-b3bf-69c3df86fbe012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-070GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]5Legacy NDC, 4 package rows20190627_1cc8add2-55d9-4215-8f7b-07a2a9f45673.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN1cc8add2-55d9-4215-8f7b-07a2a9f456735
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD1cc8add2-55d9-4215-8f7b-07a2a9f456735
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY1cc8add2-55d9-4215-8f7b-07a2a9f456735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-070-21516600070211 BLISTER PACK in 1 CARTON (51660-070-21) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-02-080000-00-00NoNoCurrent
51660-070-41516600070412 BLISTER PACK in 1 CARTON (51660-070-41) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-02-080000-00-00NoNoCurrent