NDC 61919-396

PHENERGAN

Promwthazine

PHENERGAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Promethazine Hydrochloride.

• Product ID: 61919-396_3944cd91-7185-5ad0-e054-00144ff88e88
• NDC: 61919-396
• Product Type: Human Prescription Drug
• Proprietary Name: PHENERGAN
• Generic Name: Promwthazine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040863
• Labeler Name: DIRECT RX
• Substance Name: PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/1
• Pharm Classes: Phenothiazine [EPC],Phenothiazines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-396-40

40 TABLET in 1 BOTTLE (61919-396-40)

• Marketing Start Date: 2016-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-396-40 [61919039640]

PHENERGAN TABLET

• Marketing Category: ANDA
• Application Number: ANDA040863
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-04

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	12.5 mg/1

OpenFDA Data

• SPL SET ID: 3944cd91-7184-5ad0-e054-00144ff88e88
• Manufacturer:
  • DIRECT RX
• UNII:
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 992440
  • 992438

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]

NDC Crossover Matching brand name "PHENERGAN" or generic name "Promwthazine"

NDC	Brand Name	Generic Name
0641-6082	PHENERGAN	Promethazine Hydrochloride
0641-6083	PHENERGAN	Promethazine Hydrochloride
0641-6084	PHENERGAN	Promethazine Hydrochloride
0641-6085	PHENERGAN	Promethazine Hydrochloride
61919-396	PHENERGAN	PROMWTHAZINE
70518-2656	PHENERGAN	Promethazine Hydrochloride
72189-402	Phenergan	Promethazine HCL