Ramipril
- Product NDC
- 63629-7260
- 11-digit product format
- 636297260
- Labeler code
- 63629
- Product ID
- 63629-7260_5d42a08f-068a-41a5-90a9-0f1585eb5418
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramipril
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091604
- Marketing category
- ANDA
- Marketing start
- 2011-06-08
- Marketing end
- 0000-00-00
- Substance
- RAMIPRIL
- Active strength
- 3 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 63629-7260-1 |
| excluded package | package | 63629-7260-3 |
| excluded package | package | 63629-7260-4 |
| excluded package | package | 63629-7260-2 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091604-001 | RAMIPRIL | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | |
| A091604-002 | RAMIPRIL | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | |
| A091604-003 | RAMIPRIL | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | |
| A091604-004 | RAMIPRIL | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091604-001 | AB |
| A091604-002 | AB |
| A091604-003 | AB |
| A091604-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-001 | RAMIPRIL | 1.25MG | CAPSULE / ORAL | AB | 2011-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-002 | RAMIPRIL | 2.5MG | CAPSULE / ORAL | AB | 2011-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-003 | RAMIPRIL | 5MG | CAPSULE / ORAL | AB | 2011-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-004 | RAMIPRIL | 10MG | CAPSULE / ORAL | AB | 2011-06-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091604-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091604-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091604-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091604-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091604-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091604-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091604-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091604-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091604-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091604-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091604-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091604-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091604-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091604-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091604-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091604-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091604-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091604-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091604-004 | AB | 1 | 2680178bc6a6… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
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 |
|---|---|---|---|---|---|---|
| Ramipril | RAMIPRIL | Proficient Rx LP | d3513b8b-2d8a-456d-b942-a25ec1965b04 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 091604 ANDA091604 |