Home NDC 42023-295 Daptomycin
Product NDC 42023-295
11-digit product format 420230295
Labeler code 42023
Product ID 42023-295_f210e0b8-5a7e-4ba9-b4ab-ad86a4ec8bf4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application NDA217630
Marketing category NDA
Marketing start 2025-10-27
Substance DAPTOMYCIN
Active strength 500 mg/1
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 N217630-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD 2024-11-21 N217630-002 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21
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.
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 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD 2024-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD 2024-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD 2024-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217630-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD 2024-11-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217630-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-21 a50c72e98297…
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/1
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 42023-295-01 Daptomycin 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 2 42023-295-10 Daptomycin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 2
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 · 2 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 42023-295-01 42023029501 1 in 1 VIAL, SINGLE-DOSE Historical 42023-295-10 42023029510 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01) 2025-10-27 No No Current