guaifenesin and dextromethorphan hbr

Generic: guaifenesin and dextromethorphan hbr

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hbr
Generic Name guaifenesin and dextromethorphan hbr
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-114
Product ID 43598-114_aea829a5-fc5d-7453-c533-dc4af59c329e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217340
Listing Expiration 2026-12-31
Marketing Start 2023-08-15

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598114
Hyphenated Format 43598-114

Supplemental Identifiers

RxCUI
1099074 1298324
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name guaifenesin and dextromethorphan hbr (source: ndc)
Generic Name guaifenesin and dextromethorphan hbr (source: ndc)
Application Number ANDA217340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
  • 600 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (43598-114-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (43598-114-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (43598-114-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

43598-114-01 5 BLISTER PACK in 1 CARTON (43598-114-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 43598-114-20 1 BLISTER PACK in 1 CARTON (43598-114-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 43598-114-40 2 BLISTER PACK in 1 CARTON (43598-114-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan HBR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aea829a5-fc5d-7453-c533-dc4af59c329e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074", "1298324"], "spl_set_id": ["49d7f70d-ff79-0708-3eda-efa5bf61da6c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (43598-114-01)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-114-01", "marketing_start_date": "20230815"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (43598-114-20)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-114-20", "marketing_start_date": "20230815"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (43598-114-40)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-114-40", "marketing_start_date": "20230815"}], "brand_name": "Guaifenesin and Dextromethorphan HBR", "product_id": "43598-114_aea829a5-fc5d-7453-c533-dc4af59c329e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "43598-114", "generic_name": "Guaifenesin and Dextromethorphan HBR", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan HBR", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA217340", "marketing_category": "ANDA", "marketing_start_date": "20230815", "listing_expiration_date": "20261231"}