Home NDC 60505-4946 Ceftaroline Fosamil
Product NDC 60505-4946
11-digit product format 605054946
Labeler code 60505
Product ID 60505-4946_3bf0b751-e51e-a8fa-bd01-10316e47b0f5
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 2026-09-30
Substance CEFTAROLINE FOSAMIL
Active strength 400 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 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 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 · 70 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 2026-09-14 22:38:34 2026-08 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 caaa826d4ba7…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…
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 Ceftaroline Fosamil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTAROLINE FOSAMIL 400 mg/20mL
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60505-4946-1 60505494601 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-4946-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-4946-0) 2026-09-30 No No Current