GUAIFENESIN

Product NDC
51316-070
11-digit product format
513160070
Labeler code
51316
Product ID
51316-070_cfb7375d-0de2-41b8-b06f-142d9e1fdfc9
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
NDA021282
Marketing category
NDA
Marketing start
2021-02-09
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
51316-070-682023-01-30C16284748780-1f386c649-a490-0266-e053-dadaa90a7c1aGUAIFENESIN EXTENDED-RELEASE TABLETS, 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-070-68GUAIFENESIN4 in 1 CARTONTABLET, EXTENDED RELEASE42
51316-070-68GUAIFENESIN17 in 1 BLISTER PACKTABLET, EXTENDED RELEASE172

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51316-070-68EA - Each51316-070f382fc90-6959-488a-a0ce-50b1d1fbb9de12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-070GUAIFENESIN TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]2Legacy NDC, 2 package rows20210414_564d9f72-73a5-4866-90bb-84eef35beda2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN564d9f72-73a5-4866-90bb-84eef35beda22
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD564d9f72-73a5-4866-90bb-84eef35beda22
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY564d9f72-73a5-4866-90bb-84eef35beda22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-070-68513160070684 BLISTER PACK in 1 CARTON (51316-070-68) > 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2021-02-090000-00-00NoNoCurrent