Home NDC 0409-7336-04 Ceftriaxone Sodium
Product NDC 0409-7336
Requested package NDC 0409-7336-04
11-digit product format 004097336
Labeler code 0409
Product ID 0409-7336_8e4ee031-a0df-403f-8a7e-de9626a7e501
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftriaxone Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc
Application ANDA065204
Marketing category ANDA
Marketing start 2005-07-20
Marketing end 2027-04-30
Substance CEFTRIAXONE SODIUM
Active strength 2 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065204-001 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2005-05-03 A065204-002 CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2005-05-03
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 · 82 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 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065204-001 CEFTRIAXONE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065204-002 CEFTRIAXONE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-05-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ceftriaxone Sodium Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTRIAXONE SODIUM 2 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 · 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 0409-7336-04 Ceftriaxone Sodium 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 21 0409-7336-11 Ceftriaxone Sodium 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 1 21 0409-7336-49 Ceftriaxone Sodium 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 1 20 0409-7336-49 Ceftriaxone Sodium 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFTRIAXONE SODIUM ACTIVE INGREDIENT 023Z5BR09K CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 16 CEFTRIAXONE SODIUM ACTIVE INGREDIENT 023Z5BR09K CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 16 CEFTRIAXONE ACTIVE MOIETY 75J73V1629 CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 16 CEFTRIAXONE ACTIVE MOIETY 75J73V1629 CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-7336 CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 20 Current NDC, Legacy NDC, 2 package rows 20240113_128bb292-d174-4769-b3e6-9f16617f31e3.zip 0409-7336 CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 20 Current NDC, Legacy NDC, 2 package rows 20241225_9d1f630b-e759-4395-9d01-ddc90e4fea75.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 · 2 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 0409-7336-04 00409733604 10 VIAL, SINGLE-USE in 1 CARTON (0409-7336-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7336-11) 2005-07-20 2027-04-30 No No Current