FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
65162-039
11-digit product format
651620039
Labeler code
65162
Product ID
65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-11-01
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
65162-039-03Guaifenesin and Dextromethorphan HBr30 in 1 BOTTLETABLET, EXTENDED RELEASE3015
65162-039-03Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE115
65162-039-06Guaifenesin and Dextromethorphan HBr60 in 1 BOTTLETABLET, EXTENDED RELEASE6015
65162-039-06Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE115
65162-039-17Guaifenesin and Dextromethorphan HBr2 in 1 CARTONTABLET, EXTENDED RELEASE215
65162-039-17Guaifenesin and Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-039GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 6 package rows20241027_cfdbcdb0-531a-4d95-ac5d-64d6d034b252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNcfdbcdb0-531a-4d95-ac5d-64d6d034b25215
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDcfdbcdb0-531a-4d95-ac5d-64d6d034b25215
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYcfdbcdb0-531a-4d95-ac5d-64d6d034b25215
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNb60d1cc6-086c-4483-a101-c5f8d60009695
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDb60d1cc6-086c-4483-a101-c5f8d60009695
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYb60d1cc6-086c-4483-a101-c5f8d60009695
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN187097bf-37c8-4184-a2fd-1eff9147d3704
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD187097bf-37c8-4184-a2fd-1eff9147d3704
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY187097bf-37c8-4184-a2fd-1eff9147d3704
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNebc1a915-f643-4878-9d7a-67a9c6a26b203
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN57ade7e9-1c68-456c-8853-5acdef7e8f0e3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD57ade7e9-1c68-456c-8853-5acdef7e8f0e3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDebc1a915-f643-4878-9d7a-67a9c6a26b203
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY57ade7e9-1c68-456c-8853-5acdef7e8f0e3
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYebc1a915-f643-4878-9d7a-67a9c6a26b203
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN8c9909bc-48b8-41d7-afe8-123e611a14482
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD8c9909bc-48b8-41d7-afe8-123e611a14482
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY8c9909bc-48b8-41d7-afe8-123e611a14482
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN5eb5f84f-4cb8-4552-b73d-c2b27657fa151
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN20df2ffe-5281-4cd6-adb3-3a3d28788ef61
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD5eb5f84f-4cb8-4552-b73d-c2b27657fa151
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD20df2ffe-5281-4cd6-adb3-3a3d28788ef61
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY5eb5f84f-4cb8-4552-b73d-c2b27657fa151
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY20df2ffe-5281-4cd6-adb3-3a3d28788ef61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-039-03651620039031 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-11-010000-00-00NoNoCurrent
65162-039-06651620039061 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-11-010000-00-00NoNoCurrent
65162-039-17651620039172 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-11-010000-00-00NoNoCurrent