Home NDC 70594-066 Daptomycin
Product NDC 70594-066
11-digit product format 705940066
Labeler code 70594
Product ID 70594-066_49c340b4-c825-4e34-adcf-f49be55ec2a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application NDA217415
Marketing category NDA
Marketing start 2023-11-03
Substance DAPTOMYCIN
Active strength 350 mg/7mL
Pharmacologic classes Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
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 1 .
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 N217415-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 N217415-002 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217415-001 11759497 2038-08-28 Drug product 2023-10-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 N217415-001 12629337 2043-01-09 Drug product 2026-06-10 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 N217415-002 12629337 2043-01-09 Drug product 2026-06-10
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 · 46 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 2026-02-19 14:30 UTC 2026-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a67488948f0b…
Observed Orange Book patent history# Patent history page 1 of 2 · 64 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Daptomycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPTOMYCIN 350 mg/7mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NWQ5N31VKK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403920 Internal RxNorm lookup 1996246 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 70594-066-01 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 70594-066-01 Daptomycin 7 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 7 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-066 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 5 Current NDC, 2 package rows 20240531_5e1f739a-eb81-43d8-9a14-89f32b7e1ba1.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 Marketing start Sample Exclude flag Status 70594-066-01 70594006601 1 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE 2023-11-03 No No Current