Clomipramine Hydrochloride
- Product NDC
- 59746-712
- 11-digit product format
- 597460712
- Labeler code
- 59746
- Product ID
- 59746-712_e9402f3a-49dc-49d9-8ddf-cd940bfb28a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clomipramine HCl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- JUBILANT CADISTA PHARMACEUTICALS INC.
- Application
- ANDA212218
- Marketing category
- ANDA
- Marketing start
- 2019-12-01
- Marketing end
- 0000-00-00
- Substance
- CLOMIPRAMINE HYDROCHLORIDE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 59746-712 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-712 | 59746-712-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-712 | 59746-712-30 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 59746-712 | 59746-712-90 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A212218-001 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | | 2019-10-21 |
| A212218-002 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | | 2019-10-21 |
| A212218-003 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | | 2019-10-21 |
Therapeutic equivalence codes#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 59746-712-01 | 2025-12-31 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
| 59746-712-30 | 2025-12-31 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
| 59746-712-90 | 2025-12-31 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
| 59746-712-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
| 59746-712-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
| 59746-712-90 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6ad0-d83d-e063-dadaa90ab31f | Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-712 | CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HCL) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20191201_84f5249b-c3e4-4e4a-abb6-d5b3ff6cbf4b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-712-01 | 59746071201 | 100 CAPSULE in 1 BOTTLE (59746-712-01) | 100 capsule | 2019-12-01 | 0000-00-00 | No | No | Current |
| 59746-712-30 | 59746071230 | 30 CAPSULE in 1 BOTTLE (59746-712-30) | 30 capsule | 2019-12-01 | 0000-00-00 | No | No | Current |
| 59746-712-90 | 59746071290 | 90 CAPSULE in 1 BOTTLE (59746-712-90) | 90 capsule | 2019-12-01 | 0000-00-00 | No | No | Current |