Ceftriaxone Sodium

Product NDC
67184-1005
11-digit product format
671841005
Labeler code
67184
Product ID
67184-1005_49f990ff-ec42-da5c-e063-6294a90aee7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA203702
Marketing category
ANDA
Marketing start
2016-06-29
Substance
CEFTRIAXONE SODIUM
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A203702-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203702-001AP
A203702-002AP
A203702-003AP
A203702-004AP

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 06:07:402026-07A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…

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 06:07:402026-07A203702-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004AP1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM250 mg/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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309092Internal RxNorm lookup
1665005Internal RxNorm lookup
1665021Internal RxNorm lookup
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
4cdf0743-c62b-4969-b9c9-4c6400644f6cAvailable 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
67184-1005-1Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104
67184-1005-1Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION14
67184-1005-2Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION14
67184-1005-2Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-1005CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]2Current NDC, Legacy NDC, 4 package rows20181121_4cdf0743-c62b-4969-b9c9-4c6400644f6c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
ndc (product): 67184-1005
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMAsclemed USA, Inc.f01cf0e5-caaf-4759-ba21-50f3aceff5232023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.5116231f-82d1-44be-b08e-560c9a50e5c52023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP42ba7a9d-7d2b-4eac-af59-897151a8c9242022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046cefTRIAXone 2 GM InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092cefTRIAXone 250 MG InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005cefTRIAXone 500 MG InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665021ceftriaxone 1000 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046ceftriaxone 2000 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092ceftriaxone 250 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005ceftriaxone 500 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67184-1005-16718410050110 VIAL, SINGLE-USE in 1 CARTON (67184-1005-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-06-290000-00-00NoNoCurrent
67184-1005-2671841005021 VIAL, SINGLE-USE in 1 CARTON (67184-1005-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-06-290000-00-00NoNoCurrent