Home NDC 57884-3151 Daptomycin
Product NDC 57884-3151
11-digit product format 578843151
Labeler code 57884
Product ID 57884-3151_9157d8f3-d601-579f-e053-2995a90a27de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Jiangsu Hengrui Medicine Co., Ltd.
Application ANDA212022
Marketing category ANDA
Marketing start 2019-08-22
Marketing end 0000-00-00
Substance DAPTOMYCIN
Active strength 500 mg/10mL
Pharmacologic classes Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A212022-001 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2019-08-22
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 2026-08-18 06:07:40 2026-07 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2019-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS 2019-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212022-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2019-08-22 cb3db0bc1861…
Observed Orange Book normalized TE history#