Ceftriaxone

Product NDC
0143-9768
11-digit product format
001439768
Labeler code
0143
Product ID
0143-9768_c4d2239c-f0a2-4ef8-853c-3ce83490d7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065328
Marketing category
ANDA
Marketing start
2009-08-06
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
10 g/100mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-9768IInactivated by FDA2026-08-17
excluded packagepackage0143-97680143-9768-46IInactivated 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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9768-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9768-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9768-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9768-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9768-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9768-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9768-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9768-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9768-460efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9768-46ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9768-46367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9768-46557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0143-9768-468af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0143-9768-46834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0143-9768-461332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0143-9768-46fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0143-9768-4686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0143-9768-46bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0143-9768-468dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0143-9768-46e2bbac7714bc…27bdfed8d636…

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
A065328-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065328-001AP

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 06:07:402026-07A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065328-001CEFTRIAXONEEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24e64feba35796…

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 06:07:402026-07A065328-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065328-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065328-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065328-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065328-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065328-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065328-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065328-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065328-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065328-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065328-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065328-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065328-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065328-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065328-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065328-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065328-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065328-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065328-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065328-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065328-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065328-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A065328-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065328-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065328-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065328-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A065328-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065328-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065328-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065328-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065328-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065328-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065328-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065328-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065328-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065328-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065328-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065328-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065328-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065328-001AP1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9768-462020-09-27C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-09-25C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection
0143-9768-462020-07-22C16284748780-1ab0e2407-33df-f274-e053-dbdaa90a6471Ceftriaxone for Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9768-01Ceftriaxone100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1008
0143-9768-46Ceftriaxone1 in 1 BOXINJECTION, POWDER, FOR SOLUTION18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9768CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Legacy NDC, 2 package rows20191231_e38c48f6-4d07-422b-9bb2-3c1025946e86.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
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC86ec0a92-a552-4a6d-9125-a54f95e433922026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065328
application number: ANDA065328

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSNe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone 100 MG/ML Injectable SolutionSCDe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSYe38c48f6-4d07-422b-9bb2-3c1025946e868
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSYe38c48f6-4d07-422b-9bb2-3c1025946e868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0143-9768-0100143976801100 mL in 1 VIAL100 mlHistorical
0143-9768-46001439768461 in 1 BOXHistorical