Captopril
- Product NDC
- 0143-1171
- 11-digit product format
- 001431171
- Labeler code
- 0143
- Product ID
- 0143-1171_dcd9332a-1256-457f-900a-b658c6d619c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Captopril
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA074505
- Marketing category
- ANDA
- Marketing start
- 1996-02-13
- Substance
- CAPTOPRIL
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074505-001 | CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | |
| A074505-002 | CAPTOPRIL | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | |
| A074505-003 | CAPTOPRIL | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | |
| A074505-004 | CAPTOPRIL | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074505-001 | AB |
| A074505-002 | AB |
| A074505-003 | AB |
| A074505-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | AB | 1996-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-002 | CAPTOPRIL | 25MG | TABLET / ORAL | AB | 1996-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-003 | CAPTOPRIL | 50MG | TABLET / ORAL | AB | 1996-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-004 | CAPTOPRIL | 100MG | TABLET / ORAL | AB | RS | 1996-02-13 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074505-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074505-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074505-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074505-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074505-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074505-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074505-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074505-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074505-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074505-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074505-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074505-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074505-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074505-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074505-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074505-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Captopril
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPTOPRIL | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9G64RSX1XD | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 607687f4-63cf-411c-a20b-21d238a6b7a7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5efca61-58ec-b4d0-77f8-f2b1fb112156 | Product name | 4 | 20240223 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-1171-01 | Captopril | 100 in 1 BOTTLE | TABLET | 100 | 29 | |
| 0143-1171-10 | Captopril | 1000 in 1 BOTTLE | TABLET | 1000 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-1171-01 | EA - Each | 0143-1171 | bea7623f-3f51-4d63-be73-778f58ccd2be | 1 | 2012-07-24 |
| 0143-1171-10 | EA - Each | 0143-1171 | f7d6780b-0130-4cd6-8af6-ce087409bdc9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Captopril | CAPTOPRIL | Golden State Medical Supply, Inc. | d117c8bd-50a8-7355-e053-2a95a90ac70f | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | 074505 ANDA074505 |
| Captopril | CAPTOPRIL | PD-Rx Pharmaceuticals, Inc. | 65ed6e70-f1ee-437e-965c-d1b1fdadd832 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 074505 ANDA074505 |
| Captopril | CAPTOPRIL | Hikma Pharmaceuticals USA Inc. | 607687f4-63cf-411c-a20b-21d238a6b7a7 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | 074505 ANDA074505 0143-1171 |
| Captopril | CAPTOPRIL | American Health Packaging | 9b54feb0-13cd-46a8-9924-f12880381196 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 074505 ANDA074505 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-1171-01 | 00143117101 | 100 TABLET in 1 BOTTLE (0143-1171-01) | 100 tablet | 1996-02-13 | 0000-00-00 | No | No | Current |
| 0143-1171-10 | 00143117110 | 1000 TABLET in 1 BOTTLE (0143-1171-10) | 1000 tablet | 1996-02-13 | 0000-00-00 | No | No | Current |