NDC 0904-5053

SudoGest

Pseudoephedrine Hcl

SudoGest is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Pseudoephedrine Hydrochloride.

• Product ID: 0904-5053_00efaf85-92a4-4f37-aca2-90751c54321f
• NDC: 0904-5053
• Product Type: Human Otc Drug
• Proprietary Name: SudoGest
• Generic Name: Pseudoephedrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1981-08-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Major Pharmaceuticals
• Substance Name: PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 30 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0904-5053-24

1 BLISTER PACK in 1 CARTON (0904-5053-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 1981-08-25
• Marketing End Date: 2021-11-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-5053-59 [00904505359]

SudoGest TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 1981-08-25

NDC 0904-5053-24 [00904505324]

SudoGest TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 1981-08-25
• Marketing End Date: 2021-11-11

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: d46577aa-7fd7-2130-6ed6-4b3f7562491f
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 6V9V2RYJ8N
• RxNorm Concept Unique ID - RxCUI:
  • 1049162
  • 1049160
• UPC Code:
  • 0309045053591

NDC Crossover Matching brand name "SudoGest" or generic name "Pseudoephedrine Hcl"

NDC	Brand Name	Generic Name
0904-5053	SudoGest	Pseudoephedrine HCl
0904-5125	SudoGest	Pseudoephedrine Hydrochloride
0904-5351	SudoGest	Chlorpheniramine maleate, pseudoephedrine HCl
0904-5803	SudoGest	Pseudoephedrine Hydrochloride
0904-6338	SudoGest	PSEUDOEPHEDRINE HCL
70518-0119	SudoGest	SudoGest
70518-0121	SudoGest	SudoGest
71205-133	SudoGest	SudoGest
21695-898	SudoGest	SudoGest
21695-806	SudoGest	SudoGest
33261-651	SudoGest	SudoGest
50090-0155	SudoGest	SudoGest
50090-0157	SudoGest	SudoGest
50090-1961	SudoGest	SudoGest
50090-1955	SudoGest	SudoGest
50436-0333	SudoGest	SudoGest
52959-260	SudoGest	SudoGest
63187-541	SudoGest	SudoGest
63629-1491	SudoGest	SudoGest
66336-096	SudoGest	SudoGest
0113-0432	Good Sense Nasal Decongestant	Pseudoephedrine HCl
0113-2432	Nasal Decongestant	Pseudoephedrine HCl
0363-1214	Nasal Decongestant	Pseudoephedrine HCl
0536-3607	Nasal Decongestant	Pseudoephedrine HCl
0536-4391	Nasal Decongestant	Pseudoephedrine HCl
0904-6990	Pseudoephedrine HCl	Pseudoephedrine HCl
0113-2017	sinus 12 hour	Pseudoephedrine HCl
0113-2008	sinus congestion	Pseudoephedrine HCl
0904-6754	SudoGest 12 Hour	Pseudoephedrine HCl
0904-6337	SudoGest Nasal Decongestant	Pseudoephedrine HCl
0363-0112	Wal-phed	Pseudoephedrine HCl
0363-0061	walphed d	Pseudoephedrine HCl