CLOPIDOGREL

Product NDC
31722-759
11-digit product format
317220759
Labeler code
31722
Product ID
31722-759_04d99965-cea0-8e7d-e063-6394a90ab281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205345
Marketing category
ANDA
Marketing start
2023-08-04
Substance
CLOPIDOGREL
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205345-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04
A205345-002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205345-001AB
A205345-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-048072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-041c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-04a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205345-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2023-08-049b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205345-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2023-08-049b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205345-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205345-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205345-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205345-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205345-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205345-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205345-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205345-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205345-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205345-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205345-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205345-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205345-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205345-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205345-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205345-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205345-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205345-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205345-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205345-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205345-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205345-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205345-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205345-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205345-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205345-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205345-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205345-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205345-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205345-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205345-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205345-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205345-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205345-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205345-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205345-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205345-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205345-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205345-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205345-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
CLOPIDOGREL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A74586SNO7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309362Internal RxNorm lookup
749196Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b573aefa-e337-478f-97e4-eb8472a7e497Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-759-05CLOPIDOGREL500 in 1 BOTTLETABLET5001
31722-759-30CLOPIDOGREL30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-759CLOPIDOGREL TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230910_b573aefa-e337-478f-97e4-eb8472a7e497.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOPIDOGRELCLOPIDOGRELCamber Pharmaceuticals, Inc.b573aefa-e337-478f-97e4-eb8472a7e4972023-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205345
application number: ANDA205345
ndc (product): 31722-759

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG Oral TabletPSNb573aefa-e337-478f-97e4-eb8472a7e4971
749196clopidogrel 300 MG Oral TabletSCDb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG Oral TabletSCDb573aefa-e337-478f-97e4-eb8472a7e4971
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYb573aefa-e337-478f-97e4-eb8472a7e4971
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYb573aefa-e337-478f-97e4-eb8472a7e4971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-759-0531722075905500 TABLET in 1 BOTTLE (31722-759-05) 500 tablet2023-08-04NoNoCurrent
31722-759-303172207593030 TABLET in 1 BOTTLE (31722-759-30) 30 tablet2023-08-04NoNoCurrent