Candesartan cilexetil
- Product NDC
- 63629-2126
- Requested package NDC
- 63629-2126-1
- 11-digit product format
- 636292126
- Labeler code
- 63629
- Product ID
- 63629-2126_a8c953a5-a793-42a4-a37c-51ce47e8cd7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Candesartan cilexetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA020838
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-05-21
- Marketing end
- 0000-00-00
- Substance
- CANDESARTAN CILEXETIL
- Active strength
- 4 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- 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 package | package | 63629-2126 | 63629-2126-1 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020838-001 | ATACAND | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-002 | ATACAND | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-003 | ATACAND | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-004 | ATACAND | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020838-001 | AB |
| N020838-002 | AB |
| N020838-003 | AB |
| N020838-004 | 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 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020838-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2126-1 | EA - Each | 63629-2126 | f6977265-3ec5-47fa-a2af-028e6ed345b0 | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2126 | CANDESARTAN CILEXETIL TABLET [BRYANT RANCH PREPACK] | 104 | Legacy NDC | 20231129_6b4fa8ce-8592-4569-8e24-c383c05fcf4e.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 |
|---|---|---|---|---|---|---|
| Candesartan cilexetil | CANDESARTAN CILEXETIL | Golden State Medical Supply, Inc. | 15601654-76da-04cf-e063-6394a90a2cb5 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 |
| ATACAND | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 94a59260-d2b6-464a-b5b9-bbc599e57e10 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 |
| Candesartan cilexetil | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 4621249c-1f44-4d95-8513-a1a2b1859e41 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-2126-1 | 63629212601 | 90 TABLET in 1 BOTTLE (63629-2126-1) | 90 tablet | 2021-03-10 | 0000-00-00 | No | No | Current |