guaifenesin 600 mg

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name guaifenesin 600 mg
Generic Name guaifenesin
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-110
Product ID 43598-110_ef6a6eb4-cde7-cd56-0290-29d56beec22c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215932
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 43598110
Hyphenated Format 43598-110

Supplemental Identifiers

RxCUI
310621 636522
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 600 mg (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA215932 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (43598-110-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

43598-110-01 5 BLISTER PACK in 1 CARTON (43598-110-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin 1200 mg, Guaifenesin 600 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef6a6eb4-cde7-cd56-0290-29d56beec22c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["525fda90-134c-f038-c403-eb5ffc1fb1f1"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (43598-110-01)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "43598-110-01", "marketing_start_date": "20220901"}], "brand_name": "Guaifenesin 600 mg", "product_id": "43598-110_ef6a6eb4-cde7-cd56-0290-29d56beec22c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "43598-110", "generic_name": "Guaifenesin", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA215932", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}