Home NDC 71773-050-05 Xerava
Product NDC 71773-050
Requested package NDC 71773-050-05
11-digit product format 717730050
Labeler code 71773
Product ID 71773-050_a3d105c1-c9b1-42ce-942d-34e63fdf5d83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eravacycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Tetraphase Pharmaceuticals, Inc.
Application NDA211109
Marketing category NDA
Marketing start 2018-09-10
Substance ERAVACYCLINE DIHYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Antibacterial [EPC], Tetracyclines [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 44 .
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 N211109-001 XERAVA ERAVACYCLINE DIHYDROCHLORIDE EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 N211109-002 XERAVA ERAVACYCLINE DIHYDROCHLORIDE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211109-001 8796245 2029-08-07 U-2380 2018-09-13 N211109-001 8906887 2032-08-27 Drug product 2018-09-13 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 N211109-002 8906887 2032-08-27 Drug product 2021-12-15 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 3 · 84 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 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211109-001 XERAVA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-08-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211109-002 XERAVA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-03 4b0b4de00fa7…
Observed Orange Book patent history# Patent history page 1 of 7 · 280 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 N211109-001 8796245 2029-08-07 U-2380 2018-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-001 8906887 2032-08-27 Drug product 2018-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-002 8906887 2032-08-27 Drug product 2021-12-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211109-001 8796245 2029-08-07 U-2380 2018-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-001 8906887 2032-08-27 Drug product 2018-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-002 8906887 2032-08-27 Drug product 2021-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211109-001 8796245 2029-08-07 U-2380 2018-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-001 8906887 2032-08-27 Drug product 2018-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-002 8906887 2032-08-27 Drug product 2021-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211109-001 8796245 2029-08-07 U-2380 2018-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-001 8906887 2030-12-28 Drug product 2018-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-002 8906887 2030-12-28 Drug product 2021-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-001 8796245 2029-08-07 U-2380 2018-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-001 8906887 2030-12-28 Drug product 2018-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-001 10961190 2037-10-19 Drug substance 2022-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-001 11578044 2037-10-19 Drug substance 2023-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-002 8796245 2029-08-07 U-2380 2021-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-002 8906887 2030-12-28 Drug product 2021-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-002 10961190 2037-10-19 Drug substance 2022-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211109-002 11578044 2037-10-19 Drug substance 2023-03-17 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 160 observed states.
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 Xerava
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERAVACYCLINE DIHYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK1NMH89VJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055911 Internal RxNorm lookup 2055916 Internal RxNorm lookup 2374556 Internal RxNorm lookup 2374558 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# NDC, Effective, Related label table NDC Effective Related label 71773-050-05 2023-12-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-05 2023-12-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-12 2023-12-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-12 2023-12-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-05 2023-07-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-05 2023-07-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-12 2023-07-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018 71773-050-12 2023-07-28 These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA. XERAVA ® (eravacycline) for injection, for intravenous use Initial U.S. Approval: 2018
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71773-050-05 Xerava 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 11 71773-050-05 Xerava 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 11 71773-050-12 Xerava 12 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 12 11 71773-050-12 Xerava 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71773-050 XERAVA (ERAVACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TETRAPHASE PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 4 package rows 20250410_a4b188d4-f467-470c-ad7b-25ffbdd8862a.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.
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 71773-050-05 71773005005 1 VIAL, GLASS in 1 CARTON (71773-050-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS 2018-09-10 0000-00-00 No No Current