Imipramine Hydrochloride
- Product NDC
- 50090-3148
- 11-digit product format
- 500903148
- Labeler code
- 50090
- Product ID
- 50090-3148_628d179c-a31b-4886-9f57-cb2c3fb32efd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imipramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040903
- Marketing category
- ANDA
- Marketing start
- 2016-04-07
- Substance
- IMIPRAMINE 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
- Imipramine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMIPRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BKE5Q1J60U |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-3148-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-b37b-0266-e053-dadaa90a7c1a | Imipramine Hydrochloride Tablets, USP 10 mg, 25 mg, and 50 mg Rx only Prescribing Information |
| 50090-3148-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-b37b-0266-e053-dadaa90a7c1a | Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg Rx only Prescribing Information |
| 50090-3148-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b37b-0266-e053-dadaa90a7c1a | Imipramine Hydrochloride Tablets, USP 10 mg, 25 mg, and 50 mg Rx only Prescribing Information |
| 50090-3148-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b37b-0266-e053-dadaa90a7c1a | Imipramine Hydrochloride Tablets USP 10 mg, 25 mg, and 50 mg Rx only Prescribing Information |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3148-0 | Imipramine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3148 | IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231031_d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4.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 |
|---|
| 50090-3148-0 | 50090314800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3148-0) | 2017-10-03 | 0000-00-00 | No | No | Current |