Ceftriaxone Sodium

Product NDC
50090-4689
Requested package NDC
50090-4689-0
11-digit product format
500904689
Labeler code
50090
Product ID
50090-4689_d7f0a761-0fe0-4b31-80fe-e17645faa7fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA203702
Marketing category
ANDA
Marketing start
2017-06-30
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
250 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 packagepackage50090-468950090-4689-0IInactivated 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203702-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A203702-001AP
A203702-002AP
A203702-003AP
A203702-004AP

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203702-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004AP1d8e5a09893c0…

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
50090-4689-02024-01-30C16284748780-11030e365-5409-111a-e063-dadaa90a10e2Ceftriaxone for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4689-0Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION105
50090-4689-0Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4689CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20220427_45cc1406-ec16-4578-83f3-5936a29bdb44.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMAsclemed USA, Inc.f01cf0e5-caaf-4759-ba21-50f3aceff5232023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.5116231f-82d1-44be-b08e-560c9a50e5c52023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP42ba7a9d-7d2b-4eac-af59-897151a8c9242022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309092cefTRIAXone 250 MG InjectionPSN45cc1406-ec16-4578-83f3-5936a29bdb445
309092ceftriaxone 250 MG InjectionSCD45cc1406-ec16-4578-83f3-5936a29bdb445
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY45cc1406-ec16-4578-83f3-5936a29bdb445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4689-05009046890010 VIAL, SINGLE-USE in 1 CARTON (50090-4689-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2019-11-060000-00-00NoNoCurrent