FDA.reportPublic FDA data

Maximum Strength Guaifenesin DM

Product NDC
0536-1213
11-digit product format
005361213
Labeler code
0536
Product ID
0536-1213_74767680-e4e7-4ba6-8d45-a01cd0471317
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-11-05
Marketing end
2026-09-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maximum Strength Guaifenesin DM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1213-88Maximum Strength Guaifenesin DM14 in 1 CARTONTABLET, EXTENDED RELEASE149
0536-1213-88Maximum Strength Guaifenesin DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1213-88EA - Each0536-1213c8d59758-c58c-48ac-9ab2-ad82cf5db47612018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1213MAXIMUM STRENGTH GUAIFENESIN DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20250327_2c9515f8-3120-4dbb-a7fc-d89fc5727148.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN2c9515f8-3120-4dbb-a7fc-d89fc57271489
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD2c9515f8-3120-4dbb-a7fc-d89fc57271489
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2c9515f8-3120-4dbb-a7fc-d89fc57271489
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN786607e9-ee2d-4510-8556-857032e4053f3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD786607e9-ee2d-4510-8556-857032e4053f3
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY786607e9-ee2d-4510-8556-857032e4053f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1213-880053612138814 BLISTER PACK in 1 CARTON (0536-1213-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2018-11-052026-09-28NoNoCurrent