Home NDC 44567-703 Ceftriaxone
Product NDC 44567-703
11-digit product format 445670703
Labeler code 44567
Product ID 44567-703_25b246f3-2324-45b8-94f3-657774b7cb62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftriaxone
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA065328
Marketing category ANDA
Marketing start 2008-07-24
Substance CEFTRIAXONE SODIUM
Active strength 10 g/100mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065328-001 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065328-001 AP
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 · 41 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 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065328-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-07-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ceftriaxone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTRIAXONE SODIUM 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309090 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 44567-703-01 Ceftriaxone 100 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 100 13 44567-703-01 Ceftriaxone 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-703 CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20231019_86ec0a92-a552-4a6d-9125-a54f95e43392.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 44567-703-01 44567070301 1 VIAL in 1 CARTON (44567-703-01) / 100 mL in 1 VIAL 1 vial 2019-04-05 0000-00-00 No No Current