CLOPIDOGREL

Product NDC
61919-007
11-digit product format
619190007
Labeler code
61919
Product ID
61919-007_e9d22011-7a77-3c03-e053-2995a90a673e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOPIDOGREL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090540
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-007IInactivated by FDA2026-08-17
excluded packagepackage61919-00761919-007-30IInactivated by FDA2026-08-17
excluded packagepackage61919-00761919-007-90IInactivated by FDA2026-08-17

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 1 · 31 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-007-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-007-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-007-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-007-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-007-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-007-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-007-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-007-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-007-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-007-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-007-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-007-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-007-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-007-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-007-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-007-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-007-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-007-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-007-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-007-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090540-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090540-001AB

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 06:07:402026-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173f01610625f2…
2019-09-15 20:21 UTC2019-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17e64feba35796…

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 06:07:402026-07A090540-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090540-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090540-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090540-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090540-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090540-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090540-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090540-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090540-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090540-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090540-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090540-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090540-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090540-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090540-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090540-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090540-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090540-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090540-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090540-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090540-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090540-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090540-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090540-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090540-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090540-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090540-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090540-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090540-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090540-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090540-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090540-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090540-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090540-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090540-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090540-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090540-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090540-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090540-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090540-001AB1e64feba35796…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61919-007-302025-01-30CLOPIDOGREL
61919-007-902025-01-30CLOPIDOGREL
61919-007-302020-06-18CLOPIDOGREL
61919-007-302020-01-31CLOPIDOGREL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-007-30CLOPIDOGREL30 in 1 BOTTLETABLET, FILM COATED307
61919-007-90CLOPIDOGREL90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-007-30EA - Each61919-0073d051338-9869-486c-9a36-2c5dc59520b912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-007CLOPIDOGREL TABLET, FILM COATED [DIRECT RX]7Legacy NDC, 2 package rows20230331_98a83879-4e53-41f5-83bc-681b342884dd.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClopidogrelCLOPIDOGREL BISULFATEREMEDYREPACK INC.3e2539c1-a6ad-4d60-944c-c2e7aa70ce452026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATELegacy Pharmaceutical Packaging, LLC53de10a5-dbd0-413d-90e5-00a1920ec3912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.553b4938-4462-4aeb-e054-00144ff88e882026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.55530ff3-5ce4-120f-e054-00144ff8d46c2026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEPD-Rx Pharmaceuticals, Inc.20247bf8-30ec-4807-95c1-8ec7587368ae2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEA-S Medication Solutionse19174f4-ec3c-4cd6-ad7d-d1e882f9d7b42024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEBryant Ranch Prepacke8f98886-4771-4be3-8b57-edfbbc1b46612024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEAurobindo Pharma Limited0078fb3d-3595-4ae1-a059-1d5e81c879cf2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEA-S Medication Solutionsb6e6a9b8-bf91-4e7f-b872-880afb5584262023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEProficient Rx LPec296eed-81d0-4c1e-bff4-4318518991572022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN98a83879-4e53-41f5-83bc-681b342884dd7
309362clopidogrel 75 MG Oral TabletSCD98a83879-4e53-41f5-83bc-681b342884dd7
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY98a83879-4e53-41f5-83bc-681b342884dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-007-306191900073030 TABLET, FILM COATED in 1 BOTTLE (61919-007-30) 2020-06-180000-00-00NoNoCurrent
61919-007-906191900079090 TABLET, FILM COATED in 1 BOTTLE (61919-007-90) 2014-01-010000-00-00NoNoCurrent