Home NDC 67184-1003 Cefepime
Product NDC 67184-1003
11-digit product format 671841003
Labeler code 67184
Product ID 67184-1003_34afba66-733f-4403-83d1-1b67b8a6633b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFEPIME HYDROCHLORIDE
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA203704
Marketing category ANDA
Marketing start 2016-02-01
Substance CEFEPIME HYDROCHLORIDE
Active strength 1 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203704-001 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 A203704-002 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 A203704-003 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01
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 4 · 126 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 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203704-002 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203704-003 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2016-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203704-001 CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION RS 2016-02-01 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 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 1 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665088 Internal RxNorm lookup 1665093 Internal RxNorm lookup 1665097 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 67184-1003-1 Cefepime 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 4 67184-1003-1 Cefepime 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-1003 CEFEPIME (CEFEPIME HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.] 4 Current NDC, Legacy NDC, 2 package rows 20211115_80b4c811-4a71-47fb-8565-85ce9d0f782c.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 · 4 matching rows.
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 67184-1003-1 67184100301 10 VIAL in 1 CARTON (67184-1003-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2016-02-01 0000-00-00 No No Current