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NDC 00378-0211-01 Chlordiazepoxide and Amitriptyline Hydrochloride 14; 5 mg/1; mg/1 Details
Chlordiazepoxide and Amitriptyline Hydrochloride 14; 5 mg/1; mg/1
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.
MedlinePlus Drug Summary
Amitriptyline is used to treat symptoms of depression. Amitriptyline is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.
Related Packages: 00378-0211-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amitriptyline
Chlordiazepoxide is used to relieve anxiety and to control agitation caused by alcohol withdrawal. Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 00378-0211-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlordiazepoxide
Product Information
| NDC | 00378-0211 |
|---|---|
| Product ID | 0378-0211_7dec5311-2e37-4730-a8f2-574641d6c2e8 |
| Associated GPIs | 62992002200310 |
| GCN Sequence Number | 046191 |
| GCN Sequence Number Description | amitriptyline/chlordiazepoxide TABLET 12.5MG-5MG ORAL |
| HIC3 | H2X |
| HIC3 Description | TRICYCLIC ANTIDEPRESSANT-BENZODIAZEPINE COMBINATNS |
| GCN | 16683 |
| HICL Sequence Number | 001656 |
| HICL Sequence Number Description | AMITRIPTYLINE HCL/CHLORDIAZEPOXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Chlordiazepoxide and Amitriptyline Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | chlordiazepoxide and amitriptyline hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 14; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA071297 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-0211-01 (00378021101)
| NDC Package Code | 0378-0211-01 |
|---|---|
| Billing NDC | 00378021101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01) |
| Marketing Start Date | 1986-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |