Home NDC 70594-034 Daptomycin
Product NDC 70594-034
11-digit product format 705940034
Labeler code 70594
Product ID 70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA206005
Marketing category ANDA
Marketing start 2018-10-01
Substance DAPTOMYCIN
Active strength 500 mg/10mL
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 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 A206005-001 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206005-001 AP
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 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206005-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2016-06-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Daptomycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPTOMYCIN 500 mg/10mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403920 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 70594-034-01 Daptomycin 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 14 70594-034-01 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 14 70594-034-02 Daptomycin 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 3 70594-034-02 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-034 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 14 Current NDC, Legacy NDC, 2 package rows 20231118_494b2aa1-020b-432c-977e-a5d74e31e342.zip 70594-034 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 3 Current NDC, Legacy NDC, 2 package rows 20230805_fc7eef03-042b-44a1-a344-1fa8a0435900.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 · 5 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 70594-034-01 70594003401 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01) / 10 mL in 1 VIAL, SINGLE-USE 2018-10-01 0000-00-00 No No Current 70594-034-02 70594003402 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-02) / 10 mL in 1 VIAL, SINGLE-USE 2021-05-01 0000-00-00 No No Current