NDC 0603-1587

Promethazine VC

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Promethazine VC is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Promethazine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 0603-1587_d354d495-9cf3-4e2e-a7b2-3a6ef22e260a
• NDC: 0603-1587
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine VC
• Generic Name: Promethazine Hydrochloride And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2006-12-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040654
• Labeler Name: Par Pharmaceutical
• Substance Name: PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 6 mg/5mL; mg/5mL
• Pharm Classes: Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0603-1587-58

473 mL in 1 BOTTLE (0603-1587-58)

• Marketing Start Date: 2006-12-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-1587-56 [00603158756]

Promethazine VC SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040654
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-12-07
• Marketing End Date: 2017-04-14

NDC 0603-1587-58 [00603158758]

Promethazine VC SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040654
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-12-07
• Marketing End Date: 2019-10-31

NDC 0603-1587-54 [00603158754]

Promethazine VC SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040654
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-12-07
• Marketing End Date: 2013-05-31

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

OpenFDA Data

• SPL SET ID: cf73c2e3-f43b-403f-a461-47438a7270ad
• Manufacturer:
  • Par Pharmaceutical
• UNII:
  • 04JA59TNSJ
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 1248057

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0121-0926	Promethazine VC	Promethazine Hydrochloride and Phenylephrine Hydrochloride
0603-1587	Promethazine VC	Promethazine hydrochloride and phenylephrine hydrochloride
68788-6763	Promethazine VC	Promethazinehydrochloride and phenylephrine hydrochloride
68788-9100	Promethazine VC	Promethazinehydrochloride and phenylephrine hydrochloride
50383-802	Promethazine Hydrochloride and Phenylephrine Hydrochloride	Promethazine Hydrochloride and Phenylephrine Hydrochloride