NDC 0113-2017

sinus 12 hour

Pseudoephedrine Hcl

sinus 12 hour is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by L. Perrigo Company. The primary component is Pseudoephedrine Hydrochloride.

• Product ID: 0113-2017_1d604611-9a69-4899-8aa3-a196b9f72231
• NDC: 0113-2017
• Product Type: Human Otc Drug
• Proprietary Name: sinus 12 hour
• Generic Name: Pseudoephedrine Hcl
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075153
• Labeler Name: L. Perrigo Company
• Substance Name: PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 120 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0113-2017-60

20 BLISTER PACK in 1 CARTON (0113-2017-60) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2017-09-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0113-2017-60 [00113201760]

sinus 12 hour TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075153
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-29

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

OpenFDA Data

• SPL SET ID: 26206f75-648f-47c9-8bad-25127c33961d
• Manufacturer:
  • L. Perrigo Company
• UNII:
  • 6V9V2RYJ8N
• RxNorm Concept Unique ID - RxCUI:
  • 1049154

NDC Crossover Matching brand name "sinus 12 hour" or generic name "Pseudoephedrine Hcl"

NDC	Brand Name	Generic Name
0113-2017	sinus 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
0113-2008	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
0904-6754	SudoGest 12 Hour	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