sudogest 12 hour

Generic: pseudoephedrine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sudogest 12 hour
Generic Name pseudoephedrine hcl
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6754
Product ID 0904-6754_a689a700-468b-45ac-8849-371a604587f4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Listing Expiration 2026-12-31
Marketing Start 2019-02-12

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046754
Hyphenated Format 0904-6754

Supplemental Identifiers

RxCUI
1049154 1049156
UNII
6V9V2RYJ8N

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 sudogest 12 hour (source: ndc)
Generic Name pseudoephedrine hcl (source: ndc)
Application Number ANDA075153 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0904-6754-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6754-15 10 BLISTER PACK in 1 CARTON (0904-6754-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

SudoGest 12 Hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a689a700-468b-45ac-8849-371a604587f4", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154", "1049156"], "spl_set_id": ["e829aab0-3ef0-4149-8197-96c5ce0b31d2"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0904-6754-15)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6754-15", "marketing_start_date": "20190212"}], "brand_name": "SudoGest 12 Hour", "product_id": "0904-6754_a689a700-468b-45ac-8849-371a604587f4", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0904-6754", "generic_name": "Pseudoephedrine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SudoGest 12 Hour", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_start_date": "20190212", "listing_expiration_date": "20261231"}