Home NDC 47335-894 Clopidogrel Bisulfate
Product NDC 47335-894
11-digit product format 473350894
Labeler code 47335
Product ID 47335-894_2de2d0fb-68e7-4a22-8da8-be7658468f15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel Bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090494
Marketing category ANDA
Marketing start 2012-05-18
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090494-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17
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 · 42 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 2026-08-18 06:07:40 2026-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clopidogrel Bisulfate
Listing expiration 2026-12-31 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 47335-894-13 Clopidogrel Bisulfate 500 in 1 BOTTLE TABLET, FILM COATED 500 15 47335-894-18 Clopidogrel Bisulfate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 15 47335-894-19 Clopidogrel Bisulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 15 47335-894-81 Clopidogrel Bisulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 15 47335-894-83 Clopidogrel Bisulfate 30 in 1 BOTTLE TABLET, FILM COATED 30 15
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 [SUN PHARMA GLOBAL FZE] 5 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 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 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 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 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O 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 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 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 47335-894 CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 15 Current NDC, Legacy NDC, 5 package rows 20221012_d37db064-3a5a-4a0c-a60b-b4b417fe742a.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 · 1 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 47335-894-13 47335089413 500 TABLET, FILM COATED in 1 BOTTLE (47335-894-13) 2012-05-18 0000-00-00 No No Current 47335-894-18 47335089418 1000 TABLET, FILM COATED in 1 BOTTLE (47335-894-18) 2012-05-18 0000-00-00 No No Current 47335-894-19 47335089419 90 TABLET, FILM COATED in 1 BOTTLE (47335-894-19) 2012-05-18 0000-00-00 No No Current 47335-894-81 47335089481 90 TABLET, FILM COATED in 1 BOTTLE (47335-894-81) 2012-05-18 0000-00-00 No No Current 47335-894-83 47335089483 30 TABLET, FILM COATED in 1 BOTTLE (47335-894-83) 2012-05-18 0000-00-00 No No Current