Cefepime

Product NDC
60505-6031
11-digit product format
605056031
Labeler code
60505
Product ID
60505-6031_2c523ec9-bd73-4c91-82ee-522abfd3976b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFEPIME
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corporation
Application
ANDA065369
Marketing category
ANDA
Marketing start
2007-06-18
Marketing end
0000-00-00
Substance
CEFEPIME HYDROCHLORIDE
Active strength
2 g/1
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 productproduct60505-6031DDiscontinued by firm2026-08-17
excluded packagepackage60505-603160505-6031-4DDiscontinued by firm2026-08-17

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 packagepackage60505-6031-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-6031-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-6031-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-6031-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-6031-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-6031-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-6031-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-6031-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-6031-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-6031-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-6031-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-6031-4557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065369-001CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18
A065369-002CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18
A065369-003CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065369-002CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2007-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065369-003CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2007-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065369-001CEFEPIME HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTION2007-06-181e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A065369-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065369-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065369-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065369-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065369-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065369-003AP1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6031-1EA - Each60505-60310821ffb5-7f48-430a-bf89-4d30164c9c6412016-04-04
60505-6031-4EA - Each60505-6031f76d6178-097e-48b6-9f88-c01a5e78b90912012-07-24