NDC 0904-6763

robafen

Guaifenesin

robafen is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Guaifenesin.

• Product ID: 0904-6763_2c946d4b-760f-49e7-a3ec-367b24fbeb22
• NDC: 0904-6763
• Product Type: Human Otc Drug
• Proprietary Name: robafen
• Generic Name: Guaifenesin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-13
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Major Pharmaceuticals
• Substance Name: GUAIFENESIN
• Active Ingredient Strength: 200 mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0904-6763-16

473 mL in 1 BOTTLE (0904-6763-16)

• Marketing Start Date: 2018-12-10
• Marketing End Date: 2022-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6763-16 [00904676316]

robafen SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-12-10

NDC 0904-6763-20 [00904676320]

robafen SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-13

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	200 mg/10mL

OpenFDA Data

• SPL SET ID: 25f18a65-6b39-4e0a-8bae-79d2eac5abb1
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 310604
  • 213155

NDC Crossover Matching brand name "robafen" or generic name "Guaifenesin"

NDC	Brand Name	Generic Name
0904-6464	robafen	robafen
0904-6758	robafen	robafen
0904-6763	robafen	robafen
50090-4189	robafen	robafen
50090-4343	robafen	robafen
68788-7556	robafen	robafen
68788-7663	robafen	robafen
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