Home NDC 70436-033 daptomycin
Product NDC 70436-033
11-digit product format 704360033
Labeler code 70436
Product ID 70436-033_e6b9cc81-2724-1ecb-e053-2995a90a13c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA215890
Marketing category ANDA
Marketing start 2022-10-01
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70436-033-80 daptomycin 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-033 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20221001_3890474a-4425-43b3-97d4-5370cc35c2f7.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 Units Marketing start Marketing end Sample Exclude flag Status 70436-033-80 70436003380 20 mL in 1 VIAL, SINGLE-DOSE (70436-033-80) 20 ml 2022-10-01 0000-00-00 No No Current