CEFTRIAXONE AND DEXTROSE

Product NDC
0264-3155
11-digit product format
002643155
Labeler code
0264
Product ID
0264-3155_05bf8d04-202d-472f-94b5-4f5d9020f0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFTRIAXONE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA050796
Marketing category
NDA
Marketing start
2005-04-20
Substance
CEFTRIAXONE SODIUM
Active strength
2 g/50mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERCEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20
N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERCEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050796-001AP
N050796-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050796-001CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050796-002CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRLD, RS2005-04-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N050796-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N050796-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050796-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050796-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050796-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050796-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050796-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050796-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050796-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050796-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050796-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050796-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050796-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050796-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050796-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050796-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050796-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050796-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050796-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050796-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050796-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050796-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050796-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050796-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050796-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050796-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050796-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050796-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050796-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050796-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050796-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050796-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050796-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050796-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050796-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050796-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050796-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050796-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050796-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050796-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
CEFTRIAXONE AND DEXTROSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM2 g/50mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665021Internal RxNorm lookup
1665046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67153914-16bc-490d-82d7-638061618467Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-3155-11CEFTRIAXONE AND DEXTROSE24 in 1 CASEINJECTION, SOLUTION2436
0264-3155-11CEFTRIAXONE AND DEXTROSE50 mL in 1 CONTAINERINJECTION, SOLUTION5036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3155-11EA - Each0264-3155e688ca49-87cf-483d-9eeb-a331ea20d4e412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3155CEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]36Current NDC, Legacy NDC, 2 package rows20220127_67153914-16bc-490d-82d7-638061618467.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
CEFTRIAXONE AND DEXTROSECEFTRIAXONEB. Braun Medical Inc.67153914-16bc-490d-82d7-6380616184672022-01-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 050796
application number: NDA050796
ndc (product): 0264-3155

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN67153914-16bc-490d-82d7-63806161846736
1665046cefTRIAXone 2 GM InjectionPSN67153914-16bc-490d-82d7-63806161846736
1665021ceftriaxone 1000 MG InjectionSCD67153914-16bc-490d-82d7-63806161846736
1665046ceftriaxone 2000 MG InjectionSCD67153914-16bc-490d-82d7-63806161846736
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY67153914-16bc-490d-82d7-63806161846736
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY67153914-16bc-490d-82d7-63806161846736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3155-110026431551124 CONTAINER in 1 CASE (0264-3155-11) / 50 mL in 1 CONTAINER24 container2005-04-200000-00-00NoNoCurrent