NDC 65162-679

Promethazine Hydrochloride and Phenylephrine Hydrochloride

Promethazine And Phenylephrine

Promethazine Hydrochloride and Phenylephrine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Phenylephrine Hydrochloride; Promethazine Hydrochloride.

• Product ID: 65162-679_031ac6be-40e5-4440-a04b-9e00b5adeacc
• NDC: 65162-679
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine Hydrochloride and Phenylephrine Hydrochloride
• Generic Name: Promethazine And Phenylephrine
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2009-08-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040902
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 65162-679-86

118 mL in 1 BOTTLE (65162-679-86)

• Marketing Start Date: 2009-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-679-86 [65162067986]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040902
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-25

NDC 65162-679-90 [65162067990]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040902
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-25

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4
• Manufacturer:
  • Amneal Pharmaceuticals of New York, LLC
• UNII:
  • 04JA59TNSJ
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 1248057
• UPC Code:
  • 0365162679908
  • 0365162679861

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]
• alpha-1 Adrenergic Agonist [EPC]
• Adrenergic alpha1-Agonists [MoA]

NDC Crossover Matching brand name "Promethazine Hydrochloride and Phenylephrine Hydrochloride" or generic name "Promethazine And Phenylephrine"

NDC	Brand Name	Generic Name
50383-802	Promethazine Hydrochloride and Phenylephrine Hydrochloride	Promethazine Hydrochloride and Phenylephrine Hydrochloride
65162-679	Promethazine Hydrochloride and Phenylephrine Hydrochloride	Promethazine and Phenylephrine
0121-0926	Promethazine VC	Promethazine Hydrochloride and Phenylephrine Hydrochloride
0603-1587	Promethazine VC	Promethazine hydrochloride and phenylephrine hydrochloride