guaifenesin 600 mg

Generic: guaifenesin 600 mg

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 600 mg
Generic Name guaifenesin 600 mg
Labeler marksans pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-042
Product ID 25000-042_0af3bdb4-c1f3-4941-a1de-6e08c49849cb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217780
Listing Expiration 2026-12-31
Marketing Start 2023-08-23

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 25000042
Hyphenated Format 25000-042

Supplemental Identifiers

RxCUI
310621 636522
UPC
0325000042127 0325000041120 0325000042554 0325000041342 0325000041755 0325000042011 0325000042998
UNII
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 600 mg (source: ndc)
Generic Name guaifenesin 600 mg (source: ndc)
Application Number ANDA217780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-042-01) / 20 TABLET in 1 BOTTLE
  • 500 TABLET in 1 BOTTLE (25000-042-12)
  • 2 BLISTER PACK in 1 CARTON (25000-042-55) / 10 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (25000-042-99) / 20 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

25000-042-01 1 BOTTLE in 1 CARTON (25000-042-01) / 20 TABLET in 1 BOTTLE 25000-042-12 500 TABLET in 1 BOTTLE (25000-042-12) 25000-042-55 2 BLISTER PACK in 1 CARTON (25000-042-55) / 10 TABLET in 1 BLISTER PACK 25000-042-99 2 BLISTER PACK in 1 CARTON (25000-042-99) / 20 TABLET 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": "0af3bdb4-c1f3-4941-a1de-6e08c49849cb", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0325000042127", "0325000041120", "0325000042554", "0325000041342", "0325000041755", "0325000042011", "0325000042998"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["fedf43d0-d6d1-4f50-bbab-396701e45cb2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-042-01)  / 20 TABLET in 1 BOTTLE", "package_ndc": "25000-042-01", "marketing_start_date": "20230823"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (25000-042-12)", "package_ndc": "25000-042-12", "marketing_start_date": "20230823"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-042-55)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "25000-042-55", "marketing_start_date": "20230823"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-042-99)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "25000-042-99", "marketing_start_date": "20250418"}], "brand_name": "Guaifenesin 600 mg", "product_id": "25000-042_0af3bdb4-c1f3-4941-a1de-6e08c49849cb", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "25000-042", "generic_name": "Guaifenesin 600 mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA217780", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20261231"}