NDC 0378-0442

Perphenazine and Amitriptyline Hydrochloride

Perphenazine And Amitriptyline Hydrochloride

Perphenazine and Amitriptyline Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Amitriptyline Hydrochloride; Perphenazine.

• Product ID: 0378-0442_89bf8d20-6dd5-413b-a6cd-930715065d28
• NDC: 0378-0442
• Product Type: Human Prescription Drug
• Proprietary Name: Perphenazine and Amitriptyline Hydrochloride
• Generic Name: Perphenazine And Amitriptyline Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1988-11-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071443
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
• Active Ingredient Strength: 25 mg/1; mg/1
• Pharm Classes: Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0378-0442-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01)

• Marketing Start Date: 1988-11-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0442-01 [00378044201]

Perphenazine and Amitriptyline Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA071443
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-11-10

NDC 0378-0442-05 [00378044205]

Perphenazine and Amitriptyline Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA071443
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-11-10

Drug Details

Active Ingredients

Ingredient	Strength
PERPHENAZINE	2 mg/1

OpenFDA Data

• SPL SET ID: e2937445-c015-c9a5-52f8-a2959da97290
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • FTA7XXY4EZ
  • 26LUD4JO9K
• RxNorm Concept Unique ID - RxCUI:
  • 856720
  • 856825
  • 856706
  • 856797
  • 856840

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]
• Tricyclic Antidepressant [EPC]
• Phenothiazine [EPC]
• Phenothiazines [CS]
• Tricyclic Antidepressant [EPC]

NDC Crossover Matching brand name "Perphenazine and Amitriptyline Hydrochloride" or generic name "Perphenazine And Amitriptyline Hydrochloride"

NDC	Brand Name	Generic Name
0378-0042	Perphenazine and Amitriptyline Hydrochloride	perphenazine and amitriptyline hydrochloride
0378-0073	Perphenazine and Amitriptyline Hydrochloride	perphenazine and amitriptyline hydrochloride
0378-0330	Perphenazine and Amitriptyline Hydrochloride	perphenazine and amitriptyline hydrochloride
0378-0442	Perphenazine and Amitriptyline Hydrochloride	perphenazine and amitriptyline hydrochloride
0378-0574	Perphenazine and Amitriptyline Hydrochloride	perphenazine and amitriptyline hydrochloride