FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
63304-110
11-digit product format
633040110
Labeler code
63304
Product ID
63304-110_801949ca-1baf-4a19-8466-91b4269a2c63
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
ANDA214781
Marketing category
ANDA
Marketing start
2021-07-01
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Dextromethorphan HBr
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074, 1298324

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
63304-110-54Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE17
63304-110-54Guaifenesin and Dextromethorphan HBr14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-110GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 2 package rows20221207_06328741-03e3-49cf-ae44-d4c2116e38a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN06328741-03e3-49cf-ae44-d4c2116e38a37
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN06328741-03e3-49cf-ae44-d4c2116e38a37
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD06328741-03e3-49cf-ae44-d4c2116e38a37
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD06328741-03e3-49cf-ae44-d4c2116e38a37
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY06328741-03e3-49cf-ae44-d4c2116e38a37
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY06328741-03e3-49cf-ae44-d4c2116e38a37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-110-14633040110141 BLISTER PACK in 1 CARTON (63304-110-14) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-07-010000-00-00NoNoCurrent
63304-110-54633040110541 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-07-010000-00-00NoNoCurrent