guaifenesin extended release 600 mg

Generic: guaifenesin

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin extended release 600 mg
Generic Name guaifenesin
Labeler time cap laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-723
Product ID 49483-723_10c427f2-f75b-9e93-e063-6294a90ab0ef
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217780
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

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 49483723
Hyphenated Format 49483-723

Supplemental Identifiers

RxCUI
310621 636522
UPC
0349483724707 0349483723502
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 ANDA217780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (49483-723-50)
source: ndc

Packages (1)

49483-723-50 500 TABLET in 1 BOTTLE (49483-723-50)

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": "10c427f2-f75b-9e93-e063-6294a90ab0ef", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0349483724707", "0349483723502"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["10c42869-7df0-3046-e063-6394a90aa679"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (49483-723-50)", "package_ndc": "49483-723-50", "marketing_start_date": "20240108"}], "brand_name": "Guaifenesin Extended Release 600 mg", "product_id": "49483-723_10c427f2-f75b-9e93-e063-6294a90ab0ef", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "49483-723", "generic_name": "Guaifenesin", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin Extended Release 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA217780", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}