NDC 0378-0211

Chlordiazepoxide and Amitriptyline Hydrochloride

Chlordiazepoxide And Amitriptyline Hydrochloride

Chlordiazepoxide 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; Chlordiazepoxide.

• Product ID: 0378-0211_000b3441-5518-43b7-a8a1-610378b7c501
• NDC: 0378-0211
• Product Type: Human Prescription Drug
• Proprietary Name: Chlordiazepoxide and Amitriptyline Hydrochloride
• Generic Name: Chlordiazepoxide And Amitriptyline Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1986-12-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071297
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
• Active Ingredient Strength: 14 mg/1; mg/1
• Pharm Classes: Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0378-0211-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)

• Marketing Start Date: 1986-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0211-01 [00378021101]

Chlordiazepoxide and Amitriptyline Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA071297
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-12-10

NDC 0378-0211-05 [00378021105]

Chlordiazepoxide and Amitriptyline Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA071297
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-12-10

Drug Details

Active Ingredients

Ingredient	Strength
CHLORDIAZEPOXIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 66a756f2-ac77-451c-a19a-08896d73b15c
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 6RZ6XEZ3CR
  • 26LUD4JO9K
• RxNorm Concept Unique ID - RxCUI:
  • 856769
  • 856792

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Tricyclic Antidepressant [EPC]
• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Tricyclic Antidepressant [EPC]

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

NDC	Brand Name	Generic Name
0378-0211	Chlordiazepoxide and Amitriptyline Hydrochloride	chlordiazepoxide and amitriptyline hydrochloride
0378-0277	Chlordiazepoxide and Amitriptyline Hydrochloride	chlordiazepoxide and amitriptyline hydrochloride
42571-302	Chlordiazepoxide and Amitriptyline Hydrochloride	Chlordiazepoxide and Amitriptyline Hydrochloride
42571-303	Chlordiazepoxide and Amitriptyline Hydrochloride	Chlordiazepoxide and Amitriptyline Hydrochloride