FORTAZ

Product NDC
52565-113
11-digit product format
525650113
Labeler code
52565
Product ID
52565-113_da2c70ba-ae63-494a-88d7-082b32ab4f7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftazidime sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Teligent Pharma, Inc.
Application
NDA050634
Marketing category
NDA
Marketing start
2013-04-15
Marketing end
0000-00-00
Substance
CEFTAZIDIME
Active strength
40 mg/mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52565-113DDiscontinued by firm2026-10-15
excluded packagepackage52565-11352565-113-12DDiscontinued by firm2026-10-15

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 · 24 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 packagepackage52565-113-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-113-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-113-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-113-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-113-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-113-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-113-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-113-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-113-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-113-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-113-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-113-12557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050634-001FORTAZ IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28
N050634-002FORTAZ IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28
N050634-003FORTAZ IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28c2088c7a36db…
2026-10-15 13:18:302026-09N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28c2088c7a36db…
2026-10-15 13:18:302026-09N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28c2088c7a36db…
2026-09-14 22:38:342026-08N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2884e616aacf4f…
2026-08-18 06:07:402026-07N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N050634-002FORTAZ IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N050634-003FORTAZ IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTIONRLD1989-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050634-001FORTAZ IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1989-04-2879d66fd596c7…

Reported adverse events (FAERS/openFDA)#

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