Home NDC 62034-015 clopidogrel bisulfate
Product NDC 62034-015
11-digit product format 620340015
Labeler code 62034
Product ID 62034-015_2fbe4111-2cf5-4bcd-91cc-5879b077569a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA076274
Marketing category ANDA
Marketing start 2014-02-14
Marketing end 0000-00-00
Substance CLOPIDOGREL BISULFATE
Active strength 75 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 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.
Historic NDC status page 1 of 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table 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# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table 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 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 62034-015-01 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 Initial U.S. Approval: 1997 62034-015-30 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 Initial U.S. Approval: 1997 62034-015-77 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 Initial U.S. Approval: 1997 62034-015-90 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 Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62034-015-01 clopidogrel bisulfate 100 in 1 BOTTLE TABLET, FILM COATED 100 3 62034-015-30 clopidogrel bisulfate 30 in 1 BOTTLE TABLET, FILM COATED 30 3 62034-015-77 clopidogrel bisulfate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 62034-015-77 clopidogrel bisulfate 10 in 1 CARTON TABLET, FILM COATED 10 3 62034-015-90 clopidogrel bisulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 METHYLCELLULOSE (15 MPA.S) INACTIVE INGREDIENT NPU9M2E6L8 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62034-015 CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 Legacy NDC, 5 package rows 20160128_3f359649-2dea-4ec0-a2de-d246eb0ba13c.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.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table 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 Exact identifier application applno (ANDA): 076274 application number: ANDA076274 Clopidogrel CLOPIDOGREL BISULFATE Major Pharmaceuticals 4cd07a3c-9673-4aa0-b76a-d79df2399ee1 2025-09-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274 Clopidogrel CLOPIDOGREL BISULFATE Aphena Pharma Solutions - Tennessee, LLC d49362ae-f78a-47d8-ac14-8262d621fcaa 2021-03-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 62034-015-01 62034001501 100 in 1 BOTTLE Historical 62034-015-30 62034001530 30 in 1 BOTTLE Historical 62034-015-77 62034001577 10 in 1 BLISTER PACK Historical 62034-015-90 62034001590 90 in 1 BOTTLE Historical