guaifenesin

Generic: guaifenesin

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

Drug Facts

Product Profile

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

guaifenesin 600 mg/1

Manufacturer
Ohm Laboratories, Inc.

Identifiers & Regulatory

Product NDC 51660-566
Product ID 51660-566_4aa4fb35-6f33-6e33-e063-6394a90a495e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209254
Listing Expiration 2027-12-31
Marketing Start 2022-04-01

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 51660566
Hyphenated Format 51660-566

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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA209254 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21)
  • 40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41)
  • 68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68)
source: ndc

Packages (3)

51660-566-21 20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21) 51660-566-41 40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41) 51660-566-68 68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68)

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": "4aa4fb35-6f33-6e33-e063-6394a90a495e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["7076e42a-17ff-4c42-9963-2dc02c0a5e49"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Ohm Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21)", "package_ndc": "51660-566-21", "marketing_start_date": "20220401"}, {"sample": false, "description": "40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41)", "package_ndc": "51660-566-41", "marketing_start_date": "20220401"}, {"sample": false, "description": "68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68)", "package_ndc": "51660-566-68", "marketing_start_date": "20260117"}], "brand_name": "Guaifenesin", "product_id": "51660-566_4aa4fb35-6f33-6e33-e063-6394a90a495e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "51660-566", "generic_name": "Guaifenesin", "labeler_name": "Ohm Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209254", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20271231"}