CEFTRIAXONE

Product NDC
71205-117
11-digit product format
712050117
Labeler code
71205
Product ID
71205-117_c4b25243-8960-4810-a56f-011c35dfe838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFTRIAXONE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Proficient Rx LP
Application
ANDA065125
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
2022-12-31
Substance
CEFTRIAXONE SODIUM
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-117DDiscontinued by firm2026-10-05
excluded packagepackage71205-11771205-117-01DDiscontinued by firm2026-10-05
excluded packagepackage71205-11771205-117-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-117-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-117-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-117-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-117-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-117-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-117-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-117-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-117-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-117-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-117-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-117-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-117-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-117-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-117-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71205-117-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71205-117-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71205-117-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71205-117-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71205-117-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71205-117-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71205-117-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71205-117-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71205-117-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71205-117-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065125-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30
A065125-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30
A065125-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30
A065125-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065125-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065125-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065125-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065125-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUS2003-09-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A065125-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065125-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065125-003AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065125-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065125-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065125-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065125-003AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065125-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065125-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065125-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065125-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065125-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065125-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065125-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065125-003AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065125-004AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065125-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065125-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065125-003AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065125-004AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065125-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065125-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065125-003AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065125-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A065125-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065125-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065125-003AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065125-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065125-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065125-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065125-003AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065125-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065125-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065125-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065125-003AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065125-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065125-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A065125-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A065125-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A065125-004AP13f01610625f2…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-117-01EA - Each71205-117f584de15-a9c7-4802-9d06-4ebd7568384912018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-117-01712050117011 INJECTION, POWDER, FOR SOLUTION in 1 BOX (71205-117-01) 2018-09-040000-00-00NoNoCurrent
71205-117-107120501171010 INJECTION, POWDER, FOR SOLUTION in 1 BOX (71205-117-10) 2018-09-040000-00-00NoNoCurrent