Home NDC 55648-315 Clopidogrel
Product NDC 55648-315
11-digit product format 556480315
Labeler code 55648
Product ID 55648-315_79a0b285-80de-4b38-9d3f-37fb165ef36b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA202266
Marketing category ANDA
Marketing start 2012-11-13
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 2018-12-31
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 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 A202266-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 A202266-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20
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 · 82 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 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-08-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202266-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-08-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202266-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-11-20 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-315-00 Clopidogrel 1500 in 1 POUCH TABLET, FILM COATED 1500 2 55648-315-01 Clopidogrel 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-315-02 Clopidogrel 90 in 1 BOTTLE TABLET, FILM COATED 90 2 55648-315-04 Clopidogrel 10 in 1 CARTON TABLET, FILM COATED 10 2 55648-315-04 Clopidogrel 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-315 CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 5 package rows 20121113_de099108-7445-4632-b85f-93a1bc05adf0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-315-00 55648031500 1500 in 1 POUCH Historical 55648-315-01 55648031501 30 in 1 BOTTLE Historical 55648-315-02 55648031502 90 in 1 BOTTLE Historical 55648-315-04 55648031504 10 in 1 CARTON Historical