Clopidogrel bisulfate
- Product NDC
- 62034-017
- 11-digit product format
- 620340017
- Labeler code
- 62034
- Product ID
- 62034-017_74b235fb-7b6d-4d07-ba6e-3bca30e847c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA204165
- Marketing category
- ANDA
- Marketing start
- 2016-03-01
- Marketing end
- 0000-00-00
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 62034-017 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 62034-017 | 62034-017-73 | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 62034-017-73 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 62034-017-73 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204165-001 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | |
| A204165-002 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204165-001 | AB |
| A204165-002 | 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 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204165-001 | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET / ORAL | AB | 2014-09-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204165-002 | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2014-09-15 | 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 | A204165-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204165-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204165-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204165-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204165-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204165-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204165-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204165-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204165-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204165-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204165-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204165-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204165-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204165-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204165-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204165-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204165-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204165-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204165-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204165-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204165-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204165-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204165-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204165-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204165-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204165-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204165-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204165-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204165-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A204165-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204165-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204165-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204165-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204165-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204165-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204165-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204165-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204165-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204165-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204165-002 | AB | 1 | bb7c543d1eb4… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 39fa80eb-1490-ce82-3d3a-820ae7c37b85 | Product name | 5 | 20250618 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62034-017-73 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0e3d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62034-017-11 | Clopidogrel bisulfate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 1 | |
| 62034-017-73 | Clopidogrel bisulfate | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | 1 |
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 bisulfate | CLOPIDOGREL BISULFATE | Preferred Pharmaceuticals, Inc. | e51d4bcc-01df-409d-9179-45e6536ac25b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | NCS HealthCare of KY, LLC dba Vangard Labs | 8406b8e3-e203-402f-8858-2748119e2351 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel | CLOPIDOGREL BISULFATE | AvPAK | 94a5cdc4-e063-1d46-e053-2995a90a7e15 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | REMEDYREPACK INC. | 2969deac-274b-4042-9c90-9522e62a979d | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | NuCare Pharmaceuticals,Inc. | a7bf847d-43e9-166e-e053-2995a90a239e | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel | CLOPIDOGREL BISULFATE | Proficient Rx LP | 330702d9-842c-416d-9b11-b4a9b707e9b2 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | Bryant Ranch Prepack | 539265a6-e356-42cd-bde9-ac704f108c74 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | RADHA PHARMACEUTICALS, INC. | 16aef4f6-6b90-4d5f-9e07-c9927adf3841 | 2023-11-08 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | Bryant Ranch Prepack | 7c4b3bc3-8f3b-4232-835d-e37d93b92c3e | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | ScieGen Pharmaceuticals Inc | d03cfc18-c9e4-41f8-b54d-6a7564c32afb | 2023-10-12 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel | CLOPIDOGREL BISULFATE | Westminster Pharmaceuticals, LLC | bb3b5e96-e629-4db5-8ad5-40c17c6dae18 | 2023-09-08 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel bisulfate | CLOPIDOGREL BISULFATE | Proficient Rx LP | 4842be24-3919-48ae-9302-eb9d3d921224 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
| Clopidogrel | CLOPIDOGREL | Vensun Pharmaceuticals, Inc. | 86ee71f2-850e-4c8e-87f3-c7a618d59d95 | 2019-02-19 | Boxed warning, Warnings, Adverse reactions | 204165 ANDA204165 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749196 | clopidogrel 300 MG Oral Tablet | PSN | 994dc0b4-0158-45db-965f-db827296f619 | 1 |
| 749196 | clopidogrel 300 MG Oral Tablet | SCD | 994dc0b4-0158-45db-965f-db827296f619 | 1 |
| 749196 | clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet | SY | 994dc0b4-0158-45db-965f-db827296f619 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 62034-017-11 | 62034001711 | 1 in 1 BLISTER PACK | Historical |
| 62034-017-73 | 62034001773 | 30 in 1 BOX, UNIT-DOSE | Historical |