guaifenesin

Generic: guaifenesin

Labeler: safrel pharmaceuticals, llc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

guaifenesin 1200 mg/1

Manufacturer
Safrel Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71309-461
Product ID 71309-461_f7f18eb7-a4bc-b7f6-e053-6394a90a0f74
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2020-12-18

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 71309461
Hyphenated Format 71309-461

Supplemental Identifiers

RxCUI
310621
UPC
0371309461565
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 ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56)
source: ndc

Packages (1)

71309-461-56 56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56)

Ingredients (1)

guaifenesin (1200 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": "f7f18eb7-a4bc-b7f6-e053-6394a90a0f74", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0371309461565"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["e2a3d6cb-5251-b88e-e053-2a95a90a9e30"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Safrel Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56)", "package_ndc": "71309-461-56", "marketing_start_date": "20220629"}], "brand_name": "GUAIFENESIN", "product_id": "71309-461_f7f18eb7-a4bc-b7f6-e053-6394a90a0f74", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "71309-461", "generic_name": "GUAIFENESIN", "labeler_name": "Safrel Pharmaceuticals, LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20201218", "listing_expiration_date": "20261231"}