Home Applications 206829 Application 206829
Type NDA
Sponsor CUBIST PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZERBAXA CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM POWDER;INTRAVENOUS EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N206829-001 ZERBAXA CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19
Orange Book patents# Current patent rows page 1 of 1 · 56 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206829-001 7129232 2028-05-15 U-1676 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-3360 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-3361 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-36 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-4542 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-4543 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-4547 Drug substance, Drug product 2015-01-13 N206829-001 7129232 2028-05-15 U-4550 Drug substance, Drug product 2015-01-13 N206829-001 7129232*PED 2028-11-15 Pediatric extension N206829-001 10028963 2032-09-07 U-2565 2019-07-01 N206829-001 10028963 2032-09-07 U-2566 2019-07-01 N206829-001 10028963 2032-09-07 U-4542 2019-07-01 N206829-001 10028963 2032-09-07 U-4543 2019-07-01 N206829-001 9724353 2032-09-07 U-2565 2019-07-01 N206829-001 9724353 2032-09-07 U-2566 2019-07-01 N206829-001 9724353 2032-09-07 U-4542 2019-07-01 N206829-001 9724353 2032-09-07 U-4543 2019-07-01 N206829-001 10028963*PED 2033-03-07 Pediatric extension N206829-001 9724353*PED 2033-03-07 Pediatric extension N206829-001 10420841 2034-03-14 U-1672 2019-10-21 N206829-001 10420841 2034-03-14 U-2631 2019-10-21 N206829-001 10420841 2034-03-14 U-3360 2019-10-21 N206829-001 10420841 2034-03-14 U-3361 2019-10-21 N206829-001 10420841 2034-03-14 U-4546 2019-10-21 N206829-001 10420841 2034-03-14 U-4547 2019-10-21 N206829-001 11278622 2034-03-14 U-3335 2022-04-11 N206829-001 11278622 2034-03-14 U-3336 2022-04-11 N206829-001 11278622 2034-03-14 U-4542 2022-04-11 N206829-001 11278622 2034-03-14 U-4543 2022-04-11 N206829-001 8968753 2034-03-14 U-1672 2015-03-31 N206829-001 8968753 2034-03-14 U-1673 2015-03-31 N206829-001 8968753 2034-03-14 U-3360 2015-03-31 N206829-001 8968753 2034-03-14 U-3361 2015-03-31 N206829-001 8968753 2034-03-14 U-4547 2015-03-31 N206829-001 8968753 2034-03-14 U-4550 2015-03-31 N206829-001 9320740 2034-03-14 Drug product 2016-05-25 N206829-001 9872906 2034-03-14 Drug product 2018-02-08 N206829-001 8906898 2034-05-28 Drug substance, Drug product 2015-01-13 N206829-001 10376496 2034-09-09 U-2610 2019-08-30 N206829-001 10376496 2034-09-09 U-2611 2019-08-30 N206829-001 10376496 2034-09-09 U-4548 2019-08-30 N206829-001 10376496 2034-09-09 U-4549 2019-08-30 N206829-001 10933053 2034-09-09 U-3090 2021-03-23 N206829-001 10933053 2034-09-09 U-3091 2021-03-23 N206829-001 10933053 2034-09-09 U-4544 2021-03-23 N206829-001 10933053 2034-09-09 U-4545 2021-03-23 N206829-001 10420841*PED 2034-09-14 Pediatric extension N206829-001 11278622*PED 2034-09-14 Pediatric extension N206829-001 8968753*PED 2034-09-14 Pediatric extension N206829-001 9320740*PED 2034-09-14 Pediatric extension N206829-001 9872906*PED 2034-09-14 Pediatric extension N206829-001 8906898*PED 2034-11-28 Pediatric extension N206829-001 10376496*PED 2035-03-09 Pediatric extension N206829-001 10933053*PED 2035-03-09 Pediatric extension N206829-001 10125149 2035-08-14 Drug product 2018-11-28 N206829-001 10125149*PED 2036-02-14 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206829-001 NPP 2029-05-12 N206829-001 PED 2029-11-12
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 31 · 1,220 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-36 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-1676 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-3361 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-3360 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-4550 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-4547 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-4542 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232 2028-05-15 U-4543 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 7129232*PED 2028-11-15 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10028963 2032-09-07 U-2566 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10028963 2032-09-07 U-2565 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10028963 2032-09-07 U-4542 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10028963 2032-09-07 U-4543 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9724353 2032-09-07 U-2565 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9724353 2032-09-07 U-2566 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9724353 2032-09-07 U-4542 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9724353 2032-09-07 U-4543 2019-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10028963*PED 2033-03-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9724353*PED 2033-03-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-2631 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-1672 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-3361 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-3360 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-4546 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10420841 2034-03-14 U-4547 2019-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 11278622 2034-03-14 U-3335 2022-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 11278622 2034-03-14 U-3336 2022-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 11278622 2034-03-14 U-4542 2022-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 11278622 2034-03-14 U-4543 2022-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-1673 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-1672 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-3361 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-3360 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-4550 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8968753 2034-03-14 U-4547 2015-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9320740 2034-03-14 Drug product 2016-05-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 9872906 2034-03-14 Drug product 2018-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 8906898 2034-05-28 Drug substance, Drug product 2015-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10376496 2034-09-09 U-2611 2019-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206829-001 10376496 2034-09-09 U-2610 2019-08-30 c2088c7a36db…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 105 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZERBAXA CEFTOLOZANE AND TAZOBACTAM Merck Sharp & Dohme LLC 70ac1d90-eff3-4f0b-9f46-5846c571b32f 2026-05-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 206829 application number: NDA206829 ndc (product): 67919-030
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme LLC NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme LLC NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current 67919-030 ZERBAXA ceftolozane and tazobactam Merck Sharp & Dohme Corp. NDA Current