Home NDC 0143-9478 Cefepime Hydrochloride
Product NDC 0143-9478
11-digit product format 001439478
Labeler code 0143
Product ID 0143-9478_683dbeca-503f-4314-b4d0-5386b08b19cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefepime Hydrochloride
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA214402
Marketing category ANDA
Marketing start 2025-10-31
Substance CEFEPIME HYDROCHLORIDE
Active strength 2 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214402-001 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 A214402-002 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22
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.
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 2026-09-14 22:38:34 2026-08 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214402-001 CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214402-002 CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2024-05-22 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cefepime Hydrochloride
Listing expiration 2027-12-31 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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9478-10 00143947810 10 VIAL in 1 CARTON (0143-9478-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9478-01) 10 vial 2025-10-31 No No Current