Chlordiazepoxide and Amitriptyline Hydrochloride
- Product NDC
- 0378-0211
- 11-digit product format
- 003780211
- Labeler code
- 0378
- Product ID
- 0378-0211_20875d8f-5848-4892-a7fb-ab36b0288215
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- chlordiazepoxide and amitriptyline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA071297
- Marketing category
- ANDA
- Marketing start
- 1986-12-10
- Substance
- AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
- Active strength
- 14; 5 mg/1; mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlordiazepoxide and Amitriptyline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 14 mg/1 |
| CHLORDIAZEPOXIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K, 6RZ6XEZ3CR |
| Rxcui | 856769, 856792 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0211-01 | Chlordiazepoxide and Amitriptyline Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 27 |
| 0378-0211-05 | Chlordiazepoxide and Amitriptyline Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 26LUD4JO9K | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| CHLORDIAZEPOXIDE | ACTIVE INGREDIENT | 6RZ6XEZ3CR | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| AMITRIPTYLINE | ACTIVE MOIETY | 1806D8D52K | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| CHLORDIAZEPOXIDE | ACTIVE MOIETY | 6RZ6XEZ3CR | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0211 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 24 | Current NDC, Legacy NDC, 2 package rows | 20250406_66a756f2-ac77-451c-a19a-08896d73b15c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0211-01 | 00378021101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01) | 1986-12-10 | 0000-00-00 | No | No | Current |
| 0378-0211-05 | 00378021105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05) | 1986-12-10 | 0000-00-00 | No | No | Current |