Clomipramine Hydrochloride
- Product NDC
- 52817-281
- 11-digit product format
- 528170281
- Labeler code
- 52817
- Product ID
- 52817-281_edabf702-d221-78ba-e053-2995a90ae7bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clomipramine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- TruPharma LLC
- Application
- ANDA210653
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- Marketing end
- 0000-00-00
- Substance
- CLOMIPRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | 2020-04-03 | ||
| A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | 2020-04-03 | ||
| A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | 2020-04-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | 2020-04-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | 2020-04-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | 2020-04-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-002 | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | AB | 2020-04-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-003 | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE / ORAL | AB | 2020-04-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210653-001 | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | AB | 2020-04-03 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210653-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210653-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210653-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210653-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210653-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210653-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210653-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210653-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210653-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210653-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210653-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210653-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210653-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210653-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210653-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210653-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210653-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210653-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52817-281-10 | EA - Each | 52817-281 | e6e8fd92-c4e4-4907-a5b5-c829a81c8585 | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52817-281-10 | 52817028110 | 100 CAPSULE in 1 BOTTLE (52817-281-10) | 100 capsule | 2020-09-01 | 0000-00-00 | No | No | Current |