Chlorpromazine hydrochloride
- Product NDC
- 70518-3348
- 11-digit product format
- 705183348
- Labeler code
- 70518
- Product ID
- 70518-3348_d7fb89ca-496a-4558-e053-2a95a90ab2a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorpromazine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213368
- Marketing category
- ANDA
- Marketing start
- 2022-01-28
- Marketing end
- 0000-00-00
- Substance
- CHLORPROMAZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-3348 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 70518-3348 | 70518-3348-0 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3348-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3348-0 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | |
| A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | |
| A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | |
| A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | |
| A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213368-001 | AB |
| A213368-002 | AB |
| A213368-003 | AB |
| A213368-004 | AB |
| A213368-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-001 | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2020-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-002 | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2020-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-003 | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-004 | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-01-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-005 | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2020-01-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213368-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213368-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213368-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213368-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213368-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213368-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213368-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213368-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213368-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3348 | CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 5 | Legacy NDC | 20241116_54b48a71-afcb-402c-a0e7-fb5a820fbf57.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chlorpromazine hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Northstar Rx LLC | 2bd42d3a-bf89-4d74-a252-9b914106a570 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | 213368 ANDA213368 |
| Chlorpromazine hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb63 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 213368 ANDA213368 |
| Chlorpromazine hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | 0ea5e0c6-0062-4be3-96f2-62397da3e77d | 2024-06-04 | 213368 ANDA213368 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3348-0 | 70518334800 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3348-0) | 2022-01-28 | 0000-00-00 | No | No | Current |