Home NDC 25021-106 ceftriaxone
Product NDC 25021-106
11-digit product format 250210106
Labeler code 25021
Product ID 25021-106_71bf5ebd-afe1-4906-86ef-76d7e205ec68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ceftriaxone
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA065329
Marketing category ANDA
Marketing start 2009-11-05
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25021-106-67 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25021-106-67 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25021-106-67 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25021-106-67 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25021-106-67 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25021-106-67 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25021-106-67 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25021-106-67 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25021-106-67 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 25021-106-67 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 25021-106-67 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 25021-106-67 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 126 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 2026-08-18 06:07:40 2026-07 A065329-001 CEFTRIAXONE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065329-002 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065329-003 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 25021-106-10 ceftriaxone 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 19 25021-106-10 ceftriaxone 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ceftriaxone sodium ACTIVE INGREDIENT 023Z5BR09K CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 ceftriaxone ACTIVE MOIETY 75J73V1629 CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 5 ceftriaxone sodium ACTIVE INGREDIENT 023Z5BR09K CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 ceftriaxone ACTIVE MOIETY 75J73V1629 CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-106 CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 19 Current NDC, Legacy NDC, 2 package rows 20231115_5cf93bc5-9e4c-4734-bc02-c7d0ac071022.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 ndc (product): 25021-106 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 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 25021-106-10 25021010610 25 VIAL in 1 CARTON (25021-106-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2009-11-05 0000-00-00 No No Current 25021-106-67 25021010667 25 VIAL in 1 CARTON (25021-106-67) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2015-07-01 0000-00-00 No No Current