NDC 50383-802

Promethazine Hydrochloride and Phenylephrine Hydrochloride

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Promethazine Hydrochloride and Phenylephrine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Phenylephrine Hydrochloride; Promethazine Hydrochloride.

• Product ID: 50383-802_33abeace-5a58-404c-a3bd-8a16fdc60730
• NDC: 50383-802
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine Hydrochloride and Phenylephrine Hydrochloride
• Generic Name: Promethazine Hydrochloride And Phenylephrine Hydrochloride
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2015-06-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040675
• Labeler Name: Akorn
• 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 50383-802-04

118 mL in 1 BOTTLE (50383-802-04)

• Marketing Start Date: 2015-06-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-802-04 [50383080204]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP

• Marketing Category: ANDA
• Application Number: ANDA040675
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-06-16

NDC 50383-802-16 [50383080216]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP

• Marketing Category: ANDA
• Application Number: ANDA040675
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-06-16

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: 7d0b1461-6773-4f27-9302-6a88b6f86640
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • 04JA59TNSJ
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 1248057

Pharmacological Class

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

Medicade Reported Pricing

50383080216 PROMETHAZINE-PHENYLEPHRINE SYR

Pricing Unit: ML | Drug Type:

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

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