Clopidogrel
- Product NDC
- 68084-536
- 11-digit product format
- 680840536
- Labeler code
- 68084
- Product ID
- 68084-536_2c3a4450-fdb9-1ef8-e063-6294a90ab226
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel Bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076274
- Marketing category
- ANDA
- Marketing start
- 2014-04-24
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [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 |
|---|---|---|---|---|---|---|---|
| A076274-001 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | |
| A076274-002 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076274-001 | AB |
| A076274-002 | 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 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-03-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076274-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2012-05-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076274-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2014-03-04 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076274-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076274-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076274-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076274-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076274-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076274-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076274-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076274-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076274-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076274-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076274-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076274-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076274-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076274-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076274-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076274-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076274-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076274-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076274-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076274-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076274-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076274-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076274-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076274-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076274-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076274-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076274-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076274-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076274-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076274-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076274-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076274-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076274-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076274-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076274-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076274-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076274-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076274-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076274-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076274-002 | AB | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clopidogrel
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOPIDOGREL BISULFATE | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08I79HTP27 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 39fa80eb-1490-ce82-3d3a-820ae7c37b85 | Product name | 5 | 20250618 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68084-536-01 | Clopidogrel | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | 13 | |
| 68084-536-11 | Clopidogrel | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-536-01 | EA - Each | 68084-536 | 3fb52f6f-c2a2-44f4-9031-d44a98175c70 | 1 | 2014-05-02 |
| 68084-536-11 | EA - Each | 68084-536 | 44878a9a-08be-40ac-830e-4002a1b5671f | 1 | 2014-05-02 |
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 |
|---|---|---|---|---|---|---|
| Clopidogrel | CLOPIDOGREL BISULFATE | Cardinal Health 107, LLC | c03a895c-2d74-4d7f-891f-b752ce409b68 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 076274 ANDA076274 |
| Clopidogrel | CLOPIDOGREL BISULFATE | Apotex Corp. | edae8df1-caf9-ff72-1304-5ae8b355f8e7 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 076274 ANDA076274 |
| Clopidogrel | CLOPIDOGREL BISULFATE | Major Pharmaceuticals | 4cd07a3c-9673-4aa0-b76a-d79df2399ee1 | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | 076274 ANDA076274 |
| Clopidogrel | CLOPIDOGREL BISULFATE | American Health Packaging | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | 076274 ANDA076274 68084-536 |
| Clopidogrel | CLOPIDOGREL BISULFATE | Aphena Pharma Solutions - Tennessee, LLC | d49362ae-f78a-47d8-ac14-8262d621fcaa | 2021-03-18 | Boxed warning, Warnings, Adverse reactions | 076274 ANDA076274 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749196 | clopidogrel 300 MG Oral Tablet | PSN | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 309362 | clopidogrel 75 MG Oral Tablet | PSN | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 749196 | clopidogrel 300 MG Oral Tablet | SCD | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 309362 | clopidogrel 75 MG Oral Tablet | SCD | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 749196 | clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet | SY | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 309362 | clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet | SY | 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 | 13 |
| 309362 | clopidogrel 75 MG Oral Tablet | PSN | c03a895c-2d74-4d7f-891f-b752ce409b68 | 3 |
| 309362 | clopidogrel 75 MG Oral Tablet | SCD | c03a895c-2d74-4d7f-891f-b752ce409b68 | 3 |
| 309362 | clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet | SY | c03a895c-2d74-4d7f-891f-b752ce409b68 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68084-536-01 | 68084053601 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-536-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-536-11) | 100 blister pack | 2014-04-24 | 0000-00-00 | No | No | Current |
| 68084-536-11 | 68084053611 | 1 in 1 BLISTER PACK | Historical |