Home NDC 0264-3155-11 CEFTRIAXONE AND DEXTROSE
Product NDC 0264-3155
Requested package NDC 0264-3155-11
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050796-001 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050796-002 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2005-04-20 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CEFTRIAXONE AND DEXTROSE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTRIAXONE SODIUM 2 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 023Z5BR09K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665021 Internal RxNorm lookup 1665046 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-3155-11 CEFTRIAXONE AND DEXTROSE 24 in 1 CASE INJECTION, SOLUTION 24 36 0264-3155-11 CEFTRIAXONE AND DEXTROSE 50 mL in 1 CONTAINER INJECTION, SOLUTION 50 36
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-3155 CEFTRIAXONE AND DEXTROSE (CEFTRIAXONE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 36 Current NDC, Legacy NDC, 2 package rows 20220127_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-3155-11 00264315511 24 CONTAINER in 1 CASE (0264-3155-11) / 50 mL in 1 CONTAINER 24 container 2005-04-20 0000-00-00 No No Current