Enalapril Maleate
- Product NDC
- 53808-0833
- 11-digit product format
- 538080833
- Labeler code
- 53808
- Product ID
- 53808-0833_0b7b2424-cd18-4524-b974-5266a537dda3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA075479
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- ENALAPRIL MALEATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 53808-0833 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 53808-0833 | 53808-0833-1 | I | Inactivated by FDA | 2026-08-17 |
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 | 53808-0833-1 | 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 | 53808-0833-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53808-0833-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53808-0833-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53808-0833-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53808-0833-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53808-0833-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53808-0833-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53808-0833-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53808-0833-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53808-0833-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53808-0833-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 53808-0833-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 53808-0833-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 53808-0833-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53808-0833-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 53808-0833-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 53808-0833-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 53808-0833-1 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53808-0833-1 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53808-0833-1 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075479-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075479-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075479-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075479-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075479-001 | AB |
| A075479-002 | AB |
| A075479-003 | AB |
| A075479-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075479-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075479-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075479-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075479-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075479-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075479-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075479-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075479-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075479-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075479-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075479-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075479-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075479-004 | AB | 1 | d8e5a09893c0… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ffbd585-373a-fcf5-c6c8-1f04bf28013e | Product name | 3 | 20250331 |
| 2c0b09af-323c-477d-9a19-d8165aefa3b0 | Product name | 4 | 20250107 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae | Product name | 1 | 20140508 |
| 78637fb0-95c8-441f-e4b4-db1274b6f956 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0833-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7bdc-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS USP 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0833-1 | Enalapril Maleate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0833 | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20140409_62fb98cc-d3c0-4408-8b95-78d56dfdb9ef.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 |
|---|---|---|---|---|---|---|
| Enalapril maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 9f913e79-fe6d-4ff2-9f8e-eef9df689fa8 | 2026-03-17 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ed7536f1-9a7d-4519-e053-2a95a90a4a65 | 2026-03-11 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Major Pharmaceuticals | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 2026-01-30 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f29ef93b-7380-2196-e053-2995a90a2ce3 | 2026-01-01 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f2a0bd73-0389-3f88-e053-2995a90a72e8 | 2026-01-01 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f2b3776b-02a1-311b-e053-2a95a90a2f9b | 2026-01-01 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 5c49fb37-1f09-4965-b213-5580d3a30a11 | 2025-12-30 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 7077d32e-4b06-4d48-ba0c-6db2f8ebe08c | 2025-09-26 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | Chartwell RX, LLC | b1df1832-dce4-443f-87fc-e4177d069035 | 2024-10-09 | Warnings, Adverse reactions | 075479 ANDA075479 |
| Enalapril maleate | ENALAPRIL MALEATE | A-S Medication Solutions | ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f | 2023-04-27 | Warnings, Adverse reactions | 075479 ANDA075479 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858804 | enalapril maleate 2.5 MG Oral Tablet | PSN | 62fb98cc-d3c0-4408-8b95-78d56dfdb9ef | 1 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | SCD | 62fb98cc-d3c0-4408-8b95-78d56dfdb9ef | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0833-1 | 53808083301 | 30 in 1 BLISTER PACK | Historical |