guaifenesin extended-release 600 mg

Generic: guaifenesin

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin extended-release 600 mg
Generic Name guaifenesin
Labeler guardian drug company
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-233
Product ID 53041-233_8186c3e8-1ae5-459d-8771-ad2d1ae95387
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209215
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

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 53041233
Hyphenated Format 53041-233

Supplemental Identifiers

RxCUI
310621 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 extended-release 600 mg (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA209215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (53041-233-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (53041-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (53041-233-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

53041-233-30 1 BLISTER PACK in 1 CARTON (53041-233-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 53041-233-32 2 BLISTER PACK in 1 CARTON (53041-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 53041-233-38 4 BLISTER PACK in 1 CARTON (53041-233-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8186c3e8-1ae5-459d-8771-ad2d1ae95387", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["20f9e083-419d-429d-a570-24b312ed5d2a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (53041-233-30)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "53041-233-30", "marketing_start_date": "20180301"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (53041-233-32)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "53041-233-32", "marketing_start_date": "20180301"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (53041-233-38)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "53041-233-38", "marketing_start_date": "20180301"}], "brand_name": "Guaifenesin Extended-Release 600 mg", "product_id": "53041-233_8186c3e8-1ae5-459d-8771-ad2d1ae95387", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "53041-233", "generic_name": "Guaifenesin", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin Extended-Release 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209215", "marketing_category": "ANDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}