FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBR

Product NDC
43598-231
11-digit product format
435980231
Labeler code
43598
Product ID
43598-231_e2cca72b-3d64-2919-9631-c911b77a3b0f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBR
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA217340
Marketing category
ANDA
Marketing start
2023-08-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 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
GUAIFENESIN30 mg/1
DEXTROMETHORPHAN HYDROBROMIDE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 9D2RTI9KYH
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
43598-231-01Guaifenesin and Dextromethorphan HBR5 in 1 CARTONTABLET, EXTENDED RELEASE52
43598-231-01Guaifenesin and Dextromethorphan HBR20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-231GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20240302_5e95d8c0-d521-45b6-ccaf-7786fbd14d5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-231-01435980231015 BLISTER PACK in 1 CARTON (43598-231-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2023-11-23NoNoHistorical