Home NDC 63323-340 Cefepime
Product NDC 63323-340
11-digit product format 633230340
Labeler code 63323
Product ID 63323-340_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefepime
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065441
Marketing category ANDA
Marketing start 2010-08-30
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 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 63323-340-20 Cefepime 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 11 63323-340-21 Cefepime 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-340 CEFEPIME INJECTION, POWDER, FOR SOLUTION CEFEPIME (CEFEPIME) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20231014_5e1695e0-1310-4cd8-a5da-ad1a7dcd1792.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 ndc (product): 63323-340 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
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 63323-340-20 63323034020 10 VIAL in 1 CARTON (63323-340-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-340-21) 10 vial 2010-08-30 0000-00-00 No No Current 63323-340-21 63323034021 1 in 1 VIAL Historical