Chlordiazepoxide and Amitriptyline Hydrochloride
- Product NDC
- 42571-303
- 11-digit product format
- 425710303
- Labeler code
- 42571
- Product ID
- 42571-303_3747026e-d9b9-7fb3-e063-6394a90a1641
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlordiazepoxide and Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA211925
- Marketing category
- ANDA
- Marketing start
- 2022-04-01
- Substance
- AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
- Active strength
- 10; 25 mg/1; mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlordiazepoxide and Amitriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 10 mg/1 |
| CHLORDIAZEPOXIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K, 6RZ6XEZ3CR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-303-01 | Chlordiazepoxide and Amitriptyline Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 42571-303-05 | Chlordiazepoxide and Amitriptyline Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-303 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE) TABLET CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET [MICRO LABS LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241122_b20dcdb1-50f4-4d49-a50e-be0308962f5b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42571-303-01 | 42571030301 | 100 TABLET in 1 BOTTLE (42571-303-01) | 100 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 42571-303-05 | 42571030305 | 500 TABLET in 1 BOTTLE (42571-303-05) | 500 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |