Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
49035-077
11-digit product format
490350077
Labeler code
49035
Product ID
49035-077_8d0e52eb-79d4-4ebb-85e9-9dcbee9f0a3f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALMART STORES, INC.
Application
NDA021620
Marketing category
NDA
Marketing start
2017-10-15
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1200 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
49035-077-282024-01-30C16284748780-11030e365-5faa-111a-e063-dadaa90a10e2Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets, 1200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-077-28Guaifenesin and Dextromethorphan Hydrobromide2 in 1 CARTONTABLET, EXTENDED RELEASE23
49035-077-28Guaifenesin 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
49035-077-28EA - Each49035-077af88e054-75cb-4c30-b179-f73f5b36a1f512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-077GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [WALMART STORES, INC.]3Legacy NDC, 2 package rows20200901_c063ac3d-edbb-42b6-83c7-17cdc54cc1a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNc063ac3d-edbb-42b6-83c7-17cdc54cc1a33
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDc063ac3d-edbb-42b6-83c7-17cdc54cc1a33
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYc063ac3d-edbb-42b6-83c7-17cdc54cc1a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-077-28490350077282 BLISTER PACK in 1 CARTON (49035-077-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-100000-00-00NoNoCurrent