FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
0363-0076
11-digit product format
003630076
Labeler code
0363
Product ID
0363-0076_13c678cf-bd1a-4f8f-84ec-274767c7d95b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
walgreens
Application
NDA021620
Marketing category
NDA
Marketing start
2017-09-05
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0076-142021-01-29C16284748780-1ba0f9c33-23e7-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide
0363-0076-282021-01-29C16284748780-1ba0f9c33-23e7-a910-e053-dadaa90a0b85Guaifenesin and Dextromethorphan Hydrobromide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0076-14Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
0363-0076-14Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE13
0363-0076-28Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
0363-0076-28Guaifenesin and Dextromethorphan Hydrobromide2 in 1 CARTONTABLET, EXTENDED RELEASE23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0076-14EA - Each0363-0076a6828282-4783-4c9c-86ad-3cd33bde154e12022-06-06
0363-0076-28EA - Each0363-00765702b547-c857-4748-a2e5-3606dedbe8d712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0076GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [WALGREENS]3Legacy NDC, 4 package rows20181213_3d0c04a8-9756-4555-b24c-53f074a4f4ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN3d0c04a8-9756-4555-b24c-53f074a4f4ff3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD3d0c04a8-9756-4555-b24c-53f074a4f4ff3
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3d0c04a8-9756-4555-b24c-53f074a4f4ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0363-0076-140036300761414 in 1 BLISTER PACKHistorical
0363-0076-280036300762814 in 1 BLISTER PACKHistorical