Home NDC 0781-3210 Ceftriaxone Sodium
Product NDC 0781-3210
11-digit product format 007813210
Labeler code 0781
Product ID 0781-3210_fae8140e-99cc-45f1-84d7-676288a2f327
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftriaxone Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA065168
Marketing category ANDA
Marketing start 2005-05-17
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 42 .
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 A065168-001 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065168-001 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 · 42 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 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065168-001 CEFTRIAXONE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ceftriaxone Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTRIAXONE SODIUM 10 g/100mL
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 0781-3210-46 Ceftriaxone Sodium 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 25 0781-3210-46 Ceftriaxone Sodium 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3210 CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 24 Current NDC, Legacy NDC, 2 package rows 20241215_53df951b-2eee-44b1-bae2-df7ed85bc0ed.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-3210-46 00781321046 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3210-46) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2005-05-17 0000-00-00 No No Current