Home NDC 72205-199 CLOPIDOGREL
Product NDC 72205-199
11-digit product format 722050199
Labeler code 72205
Product ID 72205-199_0b4edca9-12af-4534-baad-4fa5c1cc9ac8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOPIDOGREL BISULFATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA215388
Marketing category ANDA
Marketing start 2024-09-20
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 A215388-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215388-001 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.
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 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CLOPIDOGREL
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 72205-199-01 CLOPIDOGREL 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 72205-199-05 CLOPIDOGREL 500 in 1 BOTTLE TABLET, FILM COATED 500 2 72205-199-06 CLOPIDOGREL 10 in 1 CARTON TABLET, FILM COATED 10 2 72205-199-11 CLOPIDOGREL 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 72205-199-30 CLOPIDOGREL 30 in 1 BOTTLE TABLET, FILM COATED 30 2 72205-199-90 CLOPIDOGREL 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-199 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, 6 package rows 20241123_1447a095-c663-4f05-91d4-f09bfc0c3d42.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 Units Marketing start Sample Exclude flag Status 72205-199-01 72205019901 1000 TABLET, FILM COATED in 1 BOTTLE (72205-199-01) 2025-11-12 No No Current 72205-199-05 72205019905 500 TABLET, FILM COATED in 1 BOTTLE (72205-199-05) 2024-11-22 No No Current 72205-199-06 72205019906 10 BLISTER PACK in 1 CARTON (72205-199-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-199-11) 10 blister pack 2024-11-22 No No Current 72205-199-11 72205019911 10 in 1 BLISTER PACK Historical 72205-199-30 72205019930 30 TABLET, FILM COATED in 1 BOTTLE (72205-199-30) 2024-11-22 No No Current 72205-199-90 72205019990 90 TABLET, FILM COATED in 1 BOTTLE (72205-199-90) 2024-11-22 No No Current