NDC 0573-2952

PRIMATENE

Ephedrine Hcl, Guaifenesin

PRIMATENE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Wyeth Consumer Healthcare Llc. The primary component is Ephedrine Hydrochloride; Guaifenesin.

• Product ID: 0573-2952_4c359434-9f46-45c6-93c6-15091629ee07
• NDC: 0573-2952
• Product Type: Human Otc Drug
• Proprietary Name: PRIMATENE
• Generic Name: Ephedrine Hcl, Guaifenesin
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2004-01-06
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Wyeth Consumer Healthcare LLC
• Substance Name: EPHEDRINE HYDROCHLORIDE; GUAIFENESIN
• Active Ingredient Strength: 13 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0573-2952-10

2 BLISTER PACK in 1 CARTON (0573-2952-10) > 12 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2004-01-06
• Marketing End Date: 2023-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0573-2952-10 [00573295210]

PRIMATENE TABLET

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-01-06

NDC 0573-2952-20 [00573295220]

PRIMATENE TABLET

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-01-06

Drug Details

Active Ingredients

Ingredient	Strength
EPHEDRINE HYDROCHLORIDE	12.5 mg/1

OpenFDA Data

• SPL SET ID: 9005482c-25ae-d365-33d1-29269532c74d
• Manufacturer:
  • Wyeth Consumer Healthcare LLC
• UNII:
  • NLJ6390P1Z
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1115991
  • 1116102

NDC Crossover Matching brand name "PRIMATENE" or generic name "Ephedrine Hcl, Guaifenesin"

NDC	Brand Name	Generic Name
0573-2952	PRIMATENE	ephedrine HCl, guaifenesin
80070-600	Primatene	EPHEDRINE HYDROCHLORIDE
0363-2529	Bronchial Asthma Relief	Ephedrine HCl, Guaifenesin
0363-7430	Bronchial Asthma Relief	Ephedrine HCl, Guaifenesin