guaifenesin and pseudoephedrine hcl

Generic: guaifenesin and pseudoephedrine hcl

Labeler: dr. reddys laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hcl
Generic Name guaifenesin and pseudoephedrine hcl
Labeler dr. reddys laboratories limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Dr. Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-798
Product ID 55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208369
Listing Expiration 2026-12-31
Marketing Start 2017-12-29

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 55111798
Hyphenated Format 55111-798

Supplemental Identifiers

RxCUI
1244675 1305603
UNII
6V9V2RYJ8N 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 and pseudoephedrine hcl (source: ndc)
Generic Name guaifenesin and pseudoephedrine hcl (source: ndc)
Application Number ANDA208369 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (5)

55111-798-09 1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 55111-798-18 2 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 55111-798-35 1 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 55111-798-36 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 55111-798-41 2 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (600 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Guaifenesin and Pseudoephedrine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["6V9V2RYJ8N", "495W7451VQ"], "rxcui": ["1244675", "1305603"], "spl_set_id": ["845a2dcc-9069-3141-ae13-f2063f36d130"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dr. Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-798-09)  / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-798-09", "marketing_start_date": "20171229"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (55111-798-18)  / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-798-18", "marketing_start_date": "20171229"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-798-35)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-798-35", "marketing_start_date": "20200123"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (55111-798-36)  / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-798-36", "marketing_start_date": "20171229"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (55111-798-41)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55111-798-41", "marketing_start_date": "20200311"}], "brand_name": "Guaifenesin and Pseudoephedrine HCL", "product_id": "55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "55111-798", "generic_name": "Guaifenesin and Pseudoephedrine HCL", "labeler_name": "Dr. Reddys Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine HCL", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208369", "marketing_category": "ANDA", "marketing_start_date": "20171229", "listing_expiration_date": "20261231"}