Home NDC 71715-001 NUZYRA
Product NDC 71715-001
11-digit product format 717150001
Labeler code 71715
Product ID 71715-001_52cb2b5d-4a13-8b4a-e063-6294a90ad5b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omadacycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Paratek Pharmaceuticals, Inc.
Application NDA209817
Marketing category NDA
Marketing start 2019-02-01
Substance OMADACYCLINE
Active strength 100 mg/5mL
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 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 N209817-001 NUZYRA OMADACYCLINE TOSYLATE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02
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 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 N209817-001 10835542 2037-10-31 U-2576 2020-12-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209817-001 NCE 2023-10-02 N209817-001 GAIN 2028-10-02 N209817-001 M-320 2029-05-13
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 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209817-001 NUZYRA EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2018-10-02 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 8 · 282 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 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 7553828 2025-06-02 Drug substance 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209817-001 7553828 2025-06-02 Drug substance 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 7553828 2025-06-02 Drug substance 2019-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 9265740 2030-10-24 Drug product 2019-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 7553828 2025-06-02 Drug substance 2019-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 10124014 2029-03-05 U-2449 2018-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 9265740 2029-03-05 Drug product 2019-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 9724358 2029-03-05 U-1569 2019-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 10383884 2037-10-31 U-2576 2019-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209817-001 10835542 2037-10-31 U-2576 2020-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209817-001 7553828 2025-06-02 Drug substance 2019-07-23 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 89 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 NUZYRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMADACYCLINE 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 090IP5RV8F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2059274 Internal RxNorm lookup 2059280 Internal RxNorm lookup 2059288 Internal RxNorm lookup 2059292 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 71715-001-01 NUZYRA 10 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 10 12 71715-001-02 NUZYRA 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71715-001 NUZYRA (OMADACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NUZYRA (OMADACYCLINE) TABLET, FILM COATED [PARATEK PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250410_51591524-4703-44c6-8bde-dce3e6a463d1.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 NUZYRA OMADACYCLINE Paratek Pharmaceuticals, Inc. 51591524-4703-44c6-8bde-dce3e6a463d1 2026-05-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 209817 application number: NDA209817 ndc (product): 71715-001
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 71715-001-01 71715000101 10 mL in 1 VIAL, GLASS 10 ml Historical 71715-001-02 71715000102 10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01) 2019-02-01 0000-00-00 No No Current