NDC 36800-325

TopCare Mucus ER

Guaifenesin

TopCare Mucus ER is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Guaifenesin.

• Product ID: 36800-325_67680619-0dd0-4d29-a103-b9134f0f21ca
• NDC: 36800-325
• Product Type: Human Otc Drug
• Proprietary Name: TopCare Mucus ER
• Generic Name: Guaifenesin
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091009
• Labeler Name: Topco Associates LLC
• Substance Name: GUAIFENESIN
• Active Ingredient Strength: 1200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 36800-325-66

1 BOTTLE in 1 CARTON (36800-325-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2016-07-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-325-66 [36800032566]

TopCare Mucus ER TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091009
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-14
• Marketing End Date: 2019-01-30

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	1200 mg/1

OpenFDA Data

• SPL SET ID: 67680619-0dd0-4d29-a103-b9134f0f21ca
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 310621

NDC Crossover Matching brand name "TopCare Mucus ER" or generic name "Guaifenesin"

NDC	Brand Name	Generic Name
36800-325	TopCare Mucus ER	TopCare Mucus ER
0363-0288	childrens chest congestion	Guaifenesin
0113-0325	Good Sense Mucus ER	Guaifenesin
0113-2023	good sense mucus er	guaifenesin
0113-3650	Good Sense Mucus ER	Guaifenesin
0113-0061	good sense tussin	Guaifenesin
0121-0744	GUAIFENESIN	GUAIFENESIN
0121-1488	GUAIFENESIN	GUAIFENESIN
0121-1744	GUAIFENESIN	GUAIFENESIN
0121-2232	GUAIFENESIN	GUAIFENESIN
0363-0028	Guaifenesin	Guaifenesin
0363-0033	Guaifenesin	Guaifenesin
0363-0071	Mucus	Guaifenesin
0363-0074	Mucus	Guaifenesin
0363-0532	Mucus Relief	Guaifenesin
0363-0325	mucus relief er	Guaifenesin
0031-9303	Robitussin Direct Chest Congestion	guaifenesin
0031-8724	Robitussin Mucus Plus Chest Congestion	Guaifenesin
0113-2061	tussin	Guaifenesin
0363-0310	wal tussin	Guaifenesin