Home NDC 0143-9455 Daptomycin
Product NDC 0143-9455
11-digit product format 001439455
Labeler code 0143
Product ID 0143-9455_34a28940-21e7-4056-9ab8-dfac30198662
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA209949
Marketing category NDA
Marketing start 2026-02-25
Substance DAPTOMYCIN
Active strength 350 mg/7mL
Pharmacologic classes Lipopeptide Antibacterial [EPC], Lipopeptides [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 1 .
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 N209949-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20
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 · 41 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 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) RLD, RS 2017-10-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209949-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2017-10-20 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Daptomycin
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1996246 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 0143-9455-01 Daptomycin 7 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 7 3 0143-9455-01 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
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 0143-9455-01 00143945501 1 VIAL, SINGLE-USE in 1 CARTON (0143-9455-01) / 7 mL in 1 VIAL, SINGLE-USE 2026-02-25 No No Current