Home NDC 71045-010 Zemdri (plazomicin)
Product NDC 71045-010
11-digit product format 710450010
Labeler code 71045
Product ID 71045-010_7803b863-697d-4d96-911f-5a229bbd8272
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plazomicin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Achaogen, Inc.
Application NDA210303
Marketing category NDA
Marketing start 2018-07-16
Substance PLAZOMICIN
Active strength 500 mg/10mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N210303-001 ZEMDRI PLAZOMICIN SULFATE EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-06-25
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210303-001 8822424 2028-11-21 Drug product 2018-07-19 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 N210303-001 8383596 2032-06-25 U-2328 Drug substance 2018-07-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210303-001 NCE 2023-06-25 N210303-001 GAIN 2028-06-25
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 2026-08-18 06:07:40 2026-07 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210303-001 ZEMDRI EQ 500MG BASE/10ML (EQ 50MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2018-06-25 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210303-001 8383596 2032-06-25 U-2328 Drug substance 2018-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210303-001 8383596 2032-06-25 U-2328 Drug substance 2018-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210303-001 8822424 2028-11-21 Drug product 2018-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210303-001 9266919 2028-11-21 U-2328 2018-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210303-001 9688711 2028-11-21 U-2328 Drug substance 2018-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210303-001 8383596 2031-06-02 U-2328 Drug substance 2018-07-19 d8e5a09893c0…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zemdri (plazomicin)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PLAZOMICIN 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LYO9XZ250J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049553 Internal RxNorm lookup 2049558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71045-010-01 Zemdri (plazomicin) 10 mL in 1 VIAL INJECTION 10 1 71045-010-02 Zemdri (plazomicin) 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71045-010 ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [ACHAOGEN, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20180716_0b82ffed-27f4-4f5c-8135-670c148f0e12.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71045-010-01 71045001001 10 mL in 1 VIAL 10 ml Historical 71045-010-02 71045001002 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01) 10 vial 2018-07-16 0000-00-00 No No Current