guaifenesin

Generic: guaifenesin

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler aurohealth llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-853
Product ID 58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210453
Listing Expiration 2026-12-31
Marketing Start 2020-08-13

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 58602853
Hyphenated Format 58602-853

Supplemental Identifiers

RxCUI
636522
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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA210453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (6)

58602-853-12 1 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-853-21 1 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-853-73 1 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-853-96 1 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-853-97 2 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-853-98 5 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "af251c56-1fce-46a6-bd52-cca3425b96f9", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["84117b6e-4eeb-42b0-90b1-331f70d5a175"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-853-12)  / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-853-12", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-853-21)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-853-21", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-853-73)  / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-853-73", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-853-96)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-853-96", "marketing_start_date": "20200813"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-853-97)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-853-97", "marketing_start_date": "20200813"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (58602-853-98)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-853-98", "marketing_start_date": "20221101"}], "brand_name": "Guaifenesin", "product_id": "58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58602-853", "generic_name": "Guaifenesin", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA210453", "marketing_category": "ANDA", "marketing_start_date": "20200813", "listing_expiration_date": "20261231"}