Home NDC 71839-108 daptomycin
Product NDC 71839-108
11-digit product format 718390108
Labeler code 71839
Product ID 71839-108_9b7e93ce-5bc1-4018-85cc-9746ce516e69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler BE Pharmaceuticals Inc.
Application ANDA213425
Marketing category ANDA
Marketing start 2020-08-20
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 A213425-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213425-001 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 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) AP 2020-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) AP 2020-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) AP 2020-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / IV (INFUSION) AP 2020-08-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213425-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS AP 2020-08-20 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 71839-108-01 daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 71839-108-01 daptomycin 7 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 7 4 71839-108-10 daptomycin 7 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 7 4 71839-108-10 daptomycin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71839-108 DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BE PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 4 package rows 20220805_c305bc9f-8aeb-40de-8492-154929764daf.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 Units Marketing start Marketing end Sample Exclude flag Status 71839-108-01 71839010801 1 VIAL in 1 CARTON (71839-108-01) / 7 mL in 1 VIAL 1 vial 2020-08-20 0000-00-00 No No Current 71839-108-10 71839010810 10 VIAL in 1 CARTON (71839-108-10) / 7 mL in 1 VIAL 10 vial 2020-08-20 0000-00-00 No No Current