Home NDC 83090-011-01 daptomycin
Product NDC 83090-011
Requested package NDC 83090-011-01
11-digit product format 830900011
Labeler code 83090
Product ID 83090-011_5ef48d1a-eecc-4782-b347-7930a733e603
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Sintetica US LLC
Application ANDA215890
Marketing category ANDA
Marketing start 2023-11-05
Substance DAPTOMYCIN
Active strength 500 mg/20mL
Pharmacologic classes Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83090-011 83090-011-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83090-011 83090-011-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83090-011 83090-011-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A215890-001 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215890-001 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.
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 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2022-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2022-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2022-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215890-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-08-18 a50c72e98297…
Observed Orange Book normalized TE history# 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/20mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83090-011-01 daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2 83090-011-01 daptomycin 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83090-011 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SINTETICA US LLC] 2 Current NDC, 2 package rows 20250210_0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3.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 83090-011-01 83090001101 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-11-05 No No Current