Clomipramine Hydrochloride
- Product NDC
- 16571-683
- 11-digit product format
- 165710683
- Labeler code
- 16571
- Product ID
- 16571-683_90156b43-61b5-41ef-87e9-e044f5864a2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clomipramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA212285
- Marketing category
- ANDA
- Marketing start
- 2020-11-01
- Substance
- CLOMIPRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clomipramine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOMIPRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2LXW0L6GWJ |
| Rxcui | 857297, 857301, 857305 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-683-01 | Clomipramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 16571-683-03 | Clomipramine Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 16571-683-09 | Clomipramine Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-683 | CLOMIPRAMINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20201125_bf37fdc5-f579-48c9-baa3-8e516ac71a33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16571-683-01 | 16571068301 | 100 CAPSULE in 1 BOTTLE (16571-683-01) | 100 capsule | 2020-11-01 | 0000-00-00 | No | No | Current |
| 16571-683-03 | 16571068303 | 30 CAPSULE in 1 BOTTLE (16571-683-03) | 30 capsule | 2020-11-01 | 0000-00-00 | No | No | Current |
| 16571-683-09 | 16571068309 | 90 CAPSULE in 1 BOTTLE (16571-683-09) | 90 capsule | 2020-11-01 | 0000-00-00 | No | No | Current |