guaifenesin

Generic: guaifenesin

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler bluepoint laboratories
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-561
Product ID 68001-561_0c4ee6ca-2596-fbd2-e063-6394a90a0806
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210453
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

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 68001561
Hyphenated Format 68001-561

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
  • 8 BLISTER PACK in 1 CARTON (68001-561-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16)
source: ndc

Packages (1)

68001-561-17 8 BLISTER PACK in 1 CARTON (68001-561-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16)

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": "0c4ee6ca-2596-fbd2-e063-6394a90a0806", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["ee8a2a97-16aa-0f3e-e053-2a95a90a523b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 BLISTER PACK in 1 CARTON (68001-561-17)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16)", "package_ndc": "68001-561-17", "marketing_start_date": "20230315"}], "brand_name": "Guaifenesin", "product_id": "68001-561_0c4ee6ca-2596-fbd2-e063-6394a90a0806", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "68001-561", "generic_name": "Guaifenesin", "labeler_name": "BluePoint Laboratories", "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": "20230315", "listing_expiration_date": "20261231"}