Home NDC 68118-200 QUZYTTIR
Product NDC 68118-200
11-digit product format 681180200
Labeler code 68118
Product ID 68118-200_5c140e17-d816-0b3e-e063-6294a90afc75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler ESTEVE PHARMACEUTICALS, S.A.
Application NDA211415
Marketing category NDA
Marketing start 2019-11-13
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 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 N211415-001 QUZYTTIR CETIRIZINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211415-001 8513259 2030-02-11 U-2636 2019-10-30 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 N211415-001 8314083 2030-02-28 U-2634 2019-10-30
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 · 42 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 2026-10-15 13:18:30 2026-09 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211415-001 QUZYTTIR 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-04 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 6 · 210 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 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 8513259 2030-02-11 U-2636 2019-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 9119771 2030-02-11 U-2635 2019-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 9180090 2030-02-11 U-2635 2019-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 8263581 2030-02-28 U-2635 2019-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211415-001 8314083 2030-02-28 U-2634 2019-10-30 b8a1b40f171c…
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 QUZYTTIR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 10 mg/mL
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 QUZYTTIR CETIRIZINE HYDROCHLORIDE TerSera Therapeutics LLC f33e859d-ebc9-4d4f-a57d-204c48760d20 2026-03-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 211415 application number: NDA211415
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68118-200-10 68118020010 1 VIAL, GLASS in 1 CARTON (68118-200-10) / 1 mL in 1 VIAL, GLASS (68118-200-01) 2020-04-02 No No Current 68118-200-25 68118020025 25 VIAL, GLASS in 1 CARTON (68118-200-25) / 1 mL in 1 VIAL, GLASS (68118-200-01) 2019-11-13 No No Current