Home NDC 63323-346 Ceftriaxone
Product NDC 63323-346
11-digit product format 633230346
Labeler code 63323
Product ID 63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftriaxone
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065329
Marketing category ANDA
Marketing start 2011-06-20
Substance CEFTRIAXONE SODIUM
Active strength 1 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065329-001 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 A065329-002 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 A065329-003 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ceftriaxone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTRIAXONE SODIUM 1 g/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665005 Internal RxNorm lookup 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 63323-346-01 Ceftriaxone 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 6 63323-346-10 Ceftriaxone 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-346 CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20231021_7ea1db43-40fa-417b-8911-ae98092070a0.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ceftriaxone CEFTRIAXONE WG Critical Care, LLC 7bed9b33-29e3-4f04-9766-43a21c7ad47a 2026-01-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065329 application number: ANDA065329 Ceftriaxone CEFTRIAXONE WG Critical Care, LLC befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0 2025-04-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065329 application number: ANDA065329 ceftriaxone CEFTRIAXONE Sagent Pharmaceuticals 5cf93bc5-9e4c-4734-bc02-c7d0ac071022 2023-11-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065329 application number: ANDA065329 Ceftriaxone CEFTRIAXONE Fresenius Kabi USA, LLC 7ea1db43-40fa-417b-8911-ae98092070a0 2023-09-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065329 application number: ANDA065329 ndc (product): 63323-346 Ceftriaxone CEFTRIAXONE Proficient Rx LP fcf401df-bcdc-4773-a63b-9741c0f74b3d 2022-11-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065329 application number: ANDA065329
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 63323-346-01 63323034601 1 in 1 VIAL Historical 63323-346-10 63323034610 25 VIAL in 1 CARTON (63323-346-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01) 25 vial 2011-06-20 0000-00-00 No No Current