FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
51660-073
11-digit product format
516600073
Labeler code
51660
Product ID
51660-073_62d9d841-9307-45a7-89a7-cba5cded1462
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC
Application
NDA021620
Marketing category
NDA
Marketing start
2017-12-10
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1200 mg/1; 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
51660-073-542024-01-30C16284748780-11030e365-614d-111a-e063-dadaa90a10e2Guaifenesin 1200 mg Extended-Release Tablets & Dextromethorphan HBr 60 mg
51660-073-862024-01-30C16284748780-11030e365-614d-111a-e063-dadaa90a10e2Guaifenesin 1200 mg Extended-Release Tablets & Dextromethorphan HBr 60 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-073-54Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
51660-073-54Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE13
51660-073-86Guaifenesin and Dextromethorphan Hydrobromide2 in 1 CARTONTABLET, EXTENDED RELEASE23
51660-073-86Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-073-54EA - Each51660-0736e964448-c4fb-436c-9650-fb58e3d2d81d12019-03-12
51660-073-86EA - Each51660-0737dc7f87e-a60b-42bb-8e2c-e4e1721a203712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-073GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]3Legacy NDC, 4 package rows20181102_ed496cde-4355-45c4-80f0-84df06c32523.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNed496cde-4355-45c4-80f0-84df06c325233
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDed496cde-4355-45c4-80f0-84df06c325233
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYed496cde-4355-45c4-80f0-84df06c325233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-073-54516600073541 BLISTER PACK in 1 CARTON (51660-073-54) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-12-100000-00-00NoNoCurrent
51660-073-86516600073862 BLISTER PACK in 1 CARTON (51660-073-86) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-100000-00-00NoNoCurrent