ceftriaxone

Product NDC
25021-105
Requested package NDC
25021-105-66
11-digit product format
250210105
Labeler code
25021
Product ID
25021-105_283f5a26-664b-4645-a203-20dc88b4b8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065329
Marketing category
ANDA
Marketing start
2009-11-05
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage25021-10525021-105-66DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065329-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24
A065329-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24
A065329-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065329-001AP
A065329-002AP
A065329-003AP

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065329-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065329-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065329-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065329-001AP18072bd15b7f6…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-105-10ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2519
25021-105-10ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-105-10EA - Each25021-10580c00c45-eb5d-4644-b04d-076680e7730e12012-07-24
25021-105-66EA - Each25021-105b94f74bf-4257-4ee9-9f75-c5960afcba8b12015-07-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-105CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]19Legacy NDC, 2 package rows20231115_5cf93bc5-9e4c-4734-bc02-c7d0ac071022.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC7bed9b33-29e3-4f04-9766-43a21c7ad47a2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
CeftriaxoneCEFTRIAXONEWG Critical Care, LLCbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff02025-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ceftriaxoneCEFTRIAXONESagent Pharmaceuticals5cf93bc5-9e4c-4734-bc02-c7d0ac0710222023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 25021-105
CeftriaxoneCEFTRIAXONEFresenius Kabi USA, LLC7ea1db43-40fa-417b-8911-ae98092070a02023-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
CeftriaxoneCEFTRIAXONEProficient Rx LPfcf401df-bcdc-4773-a63b-9741c0f74b3d2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046cefTRIAXone 2 GM InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005cefTRIAXone 500 MG InjectionPSN5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665021ceftriaxone 1000 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046ceftriaxone 2000 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005ceftriaxone 500 MG InjectionSCD5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY5cf93bc5-9e4c-4734-bc02-c7d0ac07102219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-105-662502101056625 VIAL in 1 CARTON (25021-105-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2015-07-010000-00-00NoNoCurrent