Ceftriaxone Sodium

Product NDC
71205-710
11-digit product format
712050710
Labeler code
71205
Product ID
71205-710_a25ab5ea-c46d-4562-8f7e-0ccffc2ab069
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Proficient Rx LP
Application
ANDA065169
Marketing category
ANDA
Marketing start
2005-05-09
Substance
CEFTRIAXONE SODIUM
Active strength
2 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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065169-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09
A065169-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09
A065169-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09
A065169-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A065169-001AP
A065169-002AP
A065169-003AP
A065169-004AP

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRS2005-05-09d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065169-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A065169-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065169-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065169-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065169-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065169-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065169-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065169-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065169-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065169-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065169-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065169-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065169-004AP1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
023Z5BR09KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665046Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a25ab5ea-c46d-4562-8f7e-0ccffc2ab069Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-710-01Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
71205-710-01Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-710CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20221104_a25ab5ea-c46d-4562-8f7e-0ccffc2ab069.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLCddbc3bf6-5bab-4851-ae5a-ef263cd8f2552026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMREMEDYREPACK INC.9c801096-ca61-4b29-a1e1-5f7e7813b1912026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc19141ccd-e66c-49a2-a794-0616028495a72026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc03283208-8616-4117-9d2b-aa8046017a4f2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Incde028434-46cf-44f6-8ac6-889c7c6943b32025-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsb642877e-0d36-4218-afe9-0a39f35b571d2024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c2024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsff8e830a-c288-46fb-9e19-ec2017943c072024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LPa25ab5ea-c46d-4562-8f7e-0ccffc2ab0692022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065169
application number: ANDA065169
ndc (product): 71205-710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665046cefTRIAXone 2 GM InjectionPSNa25ab5ea-c46d-4562-8f7e-0ccffc2ab0691
1665046ceftriaxone 2000 MG InjectionSCDa25ab5ea-c46d-4562-8f7e-0ccffc2ab0691
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYa25ab5ea-c46d-4562-8f7e-0ccffc2ab0691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-710-01712050710011 VIAL, SINGLE-USE in 1 CARTON (71205-710-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2022-10-310000-00-00NoNoCurrent