NDC 0904-6754

SudoGest 12 Hour

Pseudoephedrine Hcl

SudoGest 12 Hour is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Pseudoephedrine Hydrochloride.

• Product ID: 0904-6754_a962b916-f01f-439c-9098-9c0e3d839e7d
• NDC: 0904-6754
• Product Type: Human Otc Drug
• Proprietary Name: SudoGest 12 Hour
• Generic Name: Pseudoephedrine Hcl
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075153
• Labeler Name: Major Pharmaceuticals
• Substance Name: PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0904-6754-15

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

• Marketing Start Date: 2019-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6754-15 [00904675415]

SudoGest 12 Hour TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075153
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-02-12

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

OpenFDA Data

• SPL SET ID: e829aab0-3ef0-4149-8197-96c5ce0b31d2
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 6V9V2RYJ8N
• RxNorm Concept Unique ID - RxCUI:
  • 1049156
  • 1049154

NDC Crossover Matching brand name "SudoGest 12 Hour" or generic name "Pseudoephedrine Hcl"

NDC	Brand Name	Generic Name
0904-6754	SudoGest 12 Hour	Pseudoephedrine HCl
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
21130-112	Nasal Decongestant	Pseudoephedrine HCl
0904-6990	Pseudoephedrine HCl	Pseudoephedrine HCl
0113-2017	sinus 12 hour	Pseudoephedrine HCl
0113-2008	sinus congestion	Pseudoephedrine HCl
11822-0112	Sinus Pressure and Congestion Relief	Pseudoephedrine HCl
11822-0650	sinus pressure and congestion relief	Pseudoephedrine HCl
0904-5053	SudoGest	Pseudoephedrine HCl
0904-6338	SudoGest	PSEUDOEPHEDRINE HCL
0904-6337	SudoGest Nasal Decongestant	Pseudoephedrine HCl
11673-112	up and up sinus 12 hour	Pseudoephedrine HCl
0363-0112	Wal-phed	Pseudoephedrine HCl
0363-0061	walphed d	Pseudoephedrine HCl