Home NDC 55111-196-90 Clopidogrel bisulfate
Product NDC 55111-196
Requested package NDC 55111-196-90
11-digit product format 551110196
Labeler code 55111
Product ID 55111-196_7fbef39d-2dec-fb75-2e25-b6a3b2d656e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddy's Laboratories Limited
Application ANDA076273
Marketing category ANDA
Marketing start 2012-05-17
Marketing end 2026-12-31
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
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076273-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076273-001 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.
Product history page 1 of 2 · 41 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 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clopidogrel bisulfate Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 75 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 309362 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 55111-196-01 Clopidogrel bisulfate 100 in 1 BOTTLE TABLET, FILM COATED 100 24 55111-196-05 Clopidogrel bisulfate 500 in 1 BOTTLE TABLET, FILM COATED 500 24 55111-196-30 Clopidogrel bisulfate 30 in 1 BOTTLE TABLET, FILM COATED 30 24 55111-196-90 Clopidogrel bisulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 24
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 [DR.REDDY'S LABORATORIES LIMITED] 12 Clopidogrel ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 Mannitol INACTIVE INGREDIENT 3OWL53L36A CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 Polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 12 Clopidogrel bisulfate ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 Clopidogrel bisulfate ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 Clopidogrel bisulfate ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 Clopidogrel ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 Clopidogrel ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 Clopidogrel ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-196 CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] 23 Current NDC, Legacy NDC, 4 package rows 20221029_b5aa951f-72de-bea1-98a2-a4085c64a361.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55111-196-90 55111019690 90 TABLET, FILM COATED in 1 BOTTLE (55111-196-90) 2012-05-17 2026-12-31 No No Current