Ceftriaxone

Product NDC
66288-6100
11-digit product format
662886100
Labeler code
66288
Product ID
66288-6100_6aff16e3-f491-4175-a3f2-842bed6ebecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Samson Medical Technologies, LLC
Application
ANDA090057
Marketing category
ANDA
Marketing start
2014-06-30
Substance
CEFTRIAXONE SODIUM
Active strength
100 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A090057-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25

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 06:07:402026-07A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-253f01610625f2…
2019-09-15 20:21 UTC2019-09A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090057-001CEFTRIAXONEEQ 100GM BASE/VIALINJECTABLE / INJECTION2014-04-25e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM100 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
023Z5BR09KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309090Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5cd2d96f-83e5-4326-ae87-d0ede4ba493aAvailable on FDA.report

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
66288-6100-1Ceftriaxone1 in 1 BAGINJECTION, POWDER, FOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66288-6100-1EA - Each66288-61006cc3300d-7e90-4977-9105-d62aa9c7d1ce12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66288-6100CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, POWDER, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES, LLC]5Current NDC, Legacy NDC, 1 package rows20230116_5cd2d96f-83e5-4326-ae87-d0ede4ba493a.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
CeftriaxoneCEFTRIAXONE SODIUMSamson Medical Technologies, LLC5cd2d96f-83e5-4326-ae87-d0ede4ba493a2023-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090057
application number: ANDA090057
ndc (product): 66288-6100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309090cefTRIAXone 100 MG/ML Injectable SolutionPSN5cd2d96f-83e5-4326-ae87-d0ede4ba493a5
309090ceftriaxone 100 MG/ML Injectable SolutionSCD5cd2d96f-83e5-4326-ae87-d0ede4ba493a5
309090ceftriaxone (as ceftriaxone sodium) 10 GM per 100 ML Injectable SolutionSY5cd2d96f-83e5-4326-ae87-d0ede4ba493a5
309090ceftriaxone (as ceftriaxone sodium) 100 GM per 1000 ML Injectable SolutionSY5cd2d96f-83e5-4326-ae87-d0ede4ba493a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66288-6100-1662886100011 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1) 2014-06-300000-00-00NoNoCurrent