Home NDC 71288-017 DAPTOMYCIN
Product NDC 71288-017
11-digit product format 712880017
Labeler code 71288
Product ID 71288-017_0d079f8d-94fb-4532-802c-415127d718de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DAPTOMYCIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA213786
Marketing category ANDA
Marketing start 2021-06-29
Substance DAPTOMYCIN
Active strength 350 mg/7mL
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 A213786-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213786-001 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 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213786-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2021-06-29 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 350 mg/7mL
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 1996246 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 71288-017-15 DAPTOMYCIN 7 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 7 8 71288-017-15 DAPTOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 8 71288-017-91 DAPTOMYCIN 7 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 7 4 71288-017-91 DAPTOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-017 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 2 package rows 20220504_4f39cddc-1cb7-41d4-a657-07f7903ee24f.zip 71288-017 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220507_191f0224-67b7-4945-bdcd-38d60645e38c.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 · 2 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 71288-017-15 71288001715 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-017-15) / 7 mL in 1 VIAL, SINGLE-DOSE 2021-06-29 0000-00-00 No No Current 71288-017-91 71288001791 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-017-91) / 7 mL in 1 VIAL, SINGLE-DOSE 2022-04-05 0000-00-00 No No Current