Home NDC 63739-178 Clopidogrel bisulfate
Product NDC 63739-178
11-digit product format 637390178
Labeler code 63739
Product ID 63739-178_2f97608b-b786-02f3-d5eb-5489e7069f8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler McKesson Corporation dba SKY Packaging
Application ANDA091023
Marketing category ANDA
Marketing start 2022-08-18
Marketing end 2027-07-31
Substance CLOPIDOGREL BISULFATE
Active strength 300 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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091023-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 A091023-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05
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 2 · 53 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 2026-02-19 14:30 UTC 2026-02 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 53 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clopidogrel bisulfate Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 08I79HTP27 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749196 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63739-178-30 Clopidogrel bisulfate 5 in 1 CARTON TABLET, FILM COATED 5 4 63739-178-30 Clopidogrel bisulfate 6 in 1 BLISTER PACK TABLET, FILM COATED 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63739-178 CLOPIDOGREL BISULFATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING] 4 Current NDC, Legacy NDC, 2 package rows 20250416_823c5dd0-f4e6-9b45-54de-a609caa8fa90.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clopidogrel bisulfate CLOPIDOGREL BISULFATE REMEDYREPACK INC. e5ee3807-5c9d-4b65-b188-4159a0fb1c85 2026-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Quallent Pharmaceuticals Health LLC d072b6ea-2bb4-8965-918e-23f9080efcb0 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE McKesson Corporation dba SKY Packaging 823c5dd0-f4e6-9b45-54de-a609caa8fa90 2025-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 ndc (product): 63739-178 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Dr.Reddy's Laboratories Inc 45caaa95-8470-b459-5f82-8156072d1878 2025-03-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Dr.Reddy's Laboratories Limited 4da4da53-91ae-4d4f-145f-255c5db443a5 2023-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63739-178-30 63739017830 5 BLISTER PACK in 1 CARTON (63739-178-30) / 6 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2022-08-18 2027-07-31 No No Current