FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBR

Product NDC
43598-115
11-digit product format
435980115
Labeler code
43598
Product ID
43598-115_aea829a5-fc5d-7453-c533-dc4af59c329e
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
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-115GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]4Current NDC20240322_49d7f70d-ff79-0708-3eda-efa5bf61da6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN49d7f70d-ff79-0708-3eda-efa5bf61da6c4
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN49d7f70d-ff79-0708-3eda-efa5bf61da6c4
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD49d7f70d-ff79-0708-3eda-efa5bf61da6c4
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD49d7f70d-ff79-0708-3eda-efa5bf61da6c4
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY49d7f70d-ff79-0708-3eda-efa5bf61da6c4
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY49d7f70d-ff79-0708-3eda-efa5bf61da6c4
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN2b59f90b-b8fc-03c0-3527-a8efa97fbfe33
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD2b59f90b-b8fc-03c0-3527-a8efa97fbfe33
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2b59f90b-b8fc-03c0-3527-a8efa97fbfe33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-115-10435980115101000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-115-10)13-SEP-23Current
43598-115-28435980115284 BLISTER PACK in 1 CARTON (43598-115-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2023-08-15NoNoCurrent
43598-115-32435980115322 BLISTER PACK in 1 CARTON (43598-115-32) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2023-08-15NoNoCurrent
43598-115-37435980115373 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) 3 blister pack2023-08-15NoNoCurrent
43598-115-42435980115426 BLISTER PACK in 1 CARTON (43598-115-42) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2023-08-15NoNoCurrent
43598-115-56435980115564 BLISTER PACK in 1 CARTON (43598-115-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) 4 blister pack2024-05-30NoNoCurrent
43598-115-70435980115701 BLISTER PACK in 1 CARTON (43598-115-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2023-08-15NoNoCurrent