Home NDC 25021-122 cefepime
Product NDC 25021-122
11-digit product format 250210122
Labeler code 25021
Product ID 25021-122_a980a9e1-16f8-41c8-a8e4-31101948966c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefepime hydrochloride
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA065441
Marketing category ANDA
Marketing start 2008-05-01
Substance CEFEPIME HYDROCHLORIDE
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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 25021-122-67 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 25021-122-67 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 25021-122-67 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 25021-122-67 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 25021-122-67 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 25021-122-67 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 25021-122-67 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 25021-122-67 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 25021-122-67 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 25021-122-67 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 25021-122-67 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065441-001 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 A065441-002 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065441-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065441-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2008-03-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base cefepime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFEPIME HYDROCHLORIDE 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I8X1O0607P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665088 Internal RxNorm lookup 1665093 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-122-50 cefepime 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 22 25021-122-50 cefepime 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cefepime hydrochloride ACTIVE INGREDIENT I8X1O0607P CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 12 cefepime ACTIVE MOIETY 807PW4VQE3 CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 12 arginine INACTIVE INGREDIENT 94ZLA3W45F CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 12 cefepime hydrochloride ACTIVE INGREDIENT I8X1O0607P CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 cefepime ACTIVE MOIETY 807PW4VQE3 CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 arginine INACTIVE INGREDIENT 94ZLA3W45F CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-122 CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 22 Current NDC, Legacy NDC, 2 package rows 20221130_de477f37-40f6-4295-ae72-a2ee36a8922e.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cefepime CEFEPIME WG Critical Care, LLC 5fd857e5-591f-44ca-80cf-fd903660b03c 2026-06-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065441 application number: ANDA065441 Cefepime CEFEPIME WG Critical Care, LLC c654ef2e-1067-4026-8931-6a0dc2a17ad1 2026-06-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065441 application number: ANDA065441 Cefepime CEFEPIME Hospira, Inc. e80c27e2-164d-4836-ba24-c160d75dc5d3 2024-11-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065441 application number: ANDA065441 Cefepime CEFEPIME Fresenius Kabi USA, LLC 5e1695e0-1310-4cd8-a5da-ad1a7dcd1792 2023-09-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065441 application number: ANDA065441 cefepime CEFEPIME HYDROCHLORIDE Sagent Pharmaceuticals de477f37-40f6-4295-ae72-a2ee36a8922e 2021-09-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065441 application number: ANDA065441 ndc (product): 25021-122
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-122-50 25021012250 10 VIAL in 1 CARTON (25021-122-50) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2008-05-01 0000-00-00 No No Current 25021-122-67 25021012267 10 VIAL in 1 CARTON (25021-122-67) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2015-07-01 0000-00-00 No No Current