Home NDC 67919-030 ZERBAXA
Product NDC 67919-030
11-digit product format 679190030
Labeler code 67919
Product ID 67919-030_23d9b7be-abf3-4ca6-bce8-d80643a708e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ceftolozane and tazobactam
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA206829
Marketing category NDA
Marketing start 2014-12-19
Substance CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Active strength 1; .5 g/10mL; g/10mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase 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 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 1 of 2 · 43 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 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206829-001 ZERBAXA EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-12-19 3a93d1ddd44b…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…
Observed Orange Book patent history# Patent history page 1 of 30 · 1,164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-36 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-1676 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-3361 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-3360 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-4550 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-4547 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-4542 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232 2028-05-15 U-4543 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 7129232*PED 2028-11-15 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10028963 2032-09-07 U-2566 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10028963 2032-09-07 U-2565 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10028963 2032-09-07 U-4542 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10028963 2032-09-07 U-4543 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9724353 2032-09-07 U-2565 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9724353 2032-09-07 U-2566 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9724353 2032-09-07 U-4542 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9724353 2032-09-07 U-4543 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10028963*PED 2033-03-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9724353*PED 2033-03-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-2631 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-1672 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-3361 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-3360 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-4546 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10420841 2034-03-14 U-4547 2019-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 11278622 2034-03-14 U-3335 2022-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 11278622 2034-03-14 U-3336 2022-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 11278622 2034-03-14 U-4542 2022-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 11278622 2034-03-14 U-4543 2022-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-1673 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-1672 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-3361 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-3360 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-4550 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8968753 2034-03-14 U-4547 2015-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9320740 2034-03-14 Drug product 2016-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 9872906 2034-03-14 Drug product 2018-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 8906898 2034-05-28 Drug substance, Drug product 2015-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10376496 2034-09-09 U-2611 2019-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206829-001 10376496 2034-09-09 U-2610 2019-08-30 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 103 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZERBAXA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFTOLOZANE SULFATE 1 g/10mL TAZOBACTAM SODIUM .5 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7R247U84HY Internal UNII lookup UXA545ABTT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597615 Internal RxNorm lookup 1597620 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67919-030-01 ZERBAXA 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 23 67919-030-01 ZERBAXA 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ceftolozane sulfate ACTIVE INGREDIENT 7R247U84HY ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 tazobactam sodium ACTIVE INGREDIENT UXA545ABTT ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 ceftolozane ACTIVE MOIETY 37A4IES95Q ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 tazobactam ACTIVE MOIETY SE10G96M8W ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 Arginine INACTIVE INGREDIENT 94ZLA3W45F ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67919-030 ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] 20 Current NDC, Legacy NDC, 2 package rows 20241114_70ac1d90-eff3-4f0b-9f46-5846c571b32f.zip
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67919-030-01 67919003001 10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2014-12-19 0000-00-00 No No Current