Home NDC 68547-578 ZEVTERA
Product NDC 68547-578
11-digit product format 685470578
Labeler code 68547
Product ID 68547-578_c5f56cce-4622-4f9f-b5c6-9fa9afd0395c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ceftobiprole medocaril sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler La Jolla Pharmaceutical Company
Application NDA218275
Marketing category NDA
Marketing start 2025-04-01
Substance CEFTOBIPROLE MEDOCARIL SODIUM
Active strength 667 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218275-001 ZEVTERA CEFTOBIPROLE MEDOCARIL SODIUM 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218275-001 NCE 2029-04-03 N218275-001 GAIN 2034-04-03
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 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD 2024-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218275-001 ZEVTERA 667MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-03 a50c72e98297…
Observed Orange Book exclusivity 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 ZEVTERA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTOBIPROLE MEDOCARIL SODIUM 667 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68547-578-01 ZEVTERA 1 in 1 VIAL, GLASS INJECTION, POWDER, FOR SOLUTION 1 4 68547-578-10 ZEVTERA 10 in 1 BOX INJECTION, POWDER, FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68547-578 ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) INJECTION, POWDER, FOR SOLUTION [LA JOLLA PHARMACEUTICAL COMPANY] 3 Current NDC, 2 package rows 20250416_2bd685df-7dc6-78a6-e063-6294a90a580b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68547-578-01 68547057801 1 in 1 VIAL, GLASS Historical 68547-578-10 68547057810 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01) 2025-04-01 No No Current