Ceftriaxone

Product NDC
68330-001
11-digit product format
683300001
Labeler code
68330
Product ID
68330-001_4e15b344-d5b4-415b-8ce1-a856dc37a13c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cephazone Pharma LLC
Application
ANDA065294
Marketing category
ANDA
Marketing start
2008-07-15
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct68330-001IInactivated by FDA2026-10-05
excluded packagepackage68330-00168330-001-10IInactivated by FDA2026-10-05

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 · 44 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 packagepackage68330-001-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68330-001-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68330-001-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68330-001-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68330-001-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68330-001-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68330-001-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68330-001-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68330-001-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68330-001-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68330-001-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68330-001-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68330-001-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68330-001-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68330-001-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68330-001-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68330-001-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68330-001-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68330-001-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68330-001-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68330-001-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68330-001-10110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065294-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26
A065294-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26
A065294-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26
A065294-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065294-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065294-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065294-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065294-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2007-03-265bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68330-001-102019-11-13C16284748780-197449f38-ce81-f6ea-e053-dbdaa90aa703CEFTRIAXONE FOR INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68330-001-01Ceftriaxone1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION12
68330-001-01Ceftriaxone1 in 1 BOXINJECTION, POWDER, FOR SOLUTION12
68330-001-10Ceftriaxone10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68330-001-01EA - Each68330-001c1b09b60-8216-4649-b160-f76678b086d712013-02-13
68330-001-10EA - Each68330-00194e91940-78cb-4996-ada4-c1f907aa6e5c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68330-001CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2Legacy NDC, 3 package rows20120908_e6ac87e3-481e-4884-ac06-1fd7279cad62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046cefTRIAXone 2 GM InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
309092cefTRIAXone 250 MG InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005cefTRIAXone 500 MG InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665021ceftriaxone 1000 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046ceftriaxone 2000 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
309092ceftriaxone 250 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005ceftriaxone 500 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68330-001-01683300001011 in 1 VIAL, GLASSHistorical
68330-001-106833000011010 in 1 CARTONHistorical