Imipramine Hydrochloride
- Product NDC
- 69315-135
- 11-digit product format
- 693150135
- Labeler code
- 69315
- Product ID
- 69315-135_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imipramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA040903
- Marketing category
- ANDA
- Marketing start
- 2016-04-07
- Substance
- IMIPRAMINE HYDROCHLORIDE
- Active strength
- 50 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
- Imipramine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMIPRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BKE5Q1J60U |
| Rxcui | 835564, 835568, 835593 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-135-01 | Imipramine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 19 |
| 69315-135-10 | Imipramine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-135 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADING PHARMA, LLC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250331_490263ce-b4d2-428a-87da-fcd07f85499a.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 |
|---|
| 69315-135-01 | 69315013501 | 100 TABLET, FILM COATED in 1 BOTTLE (69315-135-01) | 2025-12-12 | 0000-00-00 | No | No | Current |
| 69315-135-10 | 69315013510 | 1000 TABLET, FILM COATED in 1 BOTTLE (69315-135-10) | 2016-05-01 | 0000-00-00 | No | No | Current |