Home NDC 60505-6125 Ceftaroline Fosamil
Product NDC 60505-6125
11-digit product format 605056125
Labeler code 60505
Product ID 60505-6125_009f5e49-4075-974b-1178-42875743658a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftaroline Fosamil
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Apotex Corp.
Application ANDA208075
Marketing category ANDA
Marketing start 2026-02-12
Substance CEFTAROLINE FOSAMIL
Active strength 600 mg/20mL
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 1 .
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 A208075-001 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 A208075-002 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21
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 2 · 66 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 2026-02-19 14:30 UTC 2026-02 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a51e52b5d6a…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ceftaroline Fosamil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTAROLINE FOSAMIL 600 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7P6FQA5D21 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040008 Internal RxNorm lookup 1040014 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 60505-6125-0 Ceftaroline Fosamil 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 6 60505-6125-1 Ceftaroline Fosamil 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 6
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-6125-0 60505612500 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 60505-6125-1 60505612501 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6125-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6125-0) 2026-02-12 No No Current