Home NDC 16729-435 DAPTOMYCIN
Product NDC 16729-435
11-digit product format 167290435
Labeler code 16729
Product ID 16729-435_40bc0f77-d6a8-2765-e063-6294a90a800a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application ANDA211961
Marketing category ANDA
Marketing start 2019-06-24
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 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 A211961-001 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211961-001 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 · 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 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211961-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-06-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 16729-435-05 DAPTOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 16729-435-05 DAPTOMYCIN 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-435 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241108_956b068f-5958-49eb-9c9f-3b6e324e77d2.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.
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 16729-435-05 16729043505 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-435-05) / 10 mL in 1 VIAL, SINGLE-DOSE 2019-06-24 0000-00-00 No No Current