Home NDC 72572-158 Daptomycin
Product NDC 72572-158
11-digit product format 725720158
Labeler code 72572
Product ID 72572-158_e2ab4847-abf9-417b-8270-50c7dd7fd288
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Civica, Inc.
Application NDA217415
Marketing category NDA
Marketing start 2025-11-28
Substance DAPTOMYCIN
Active strength 500 mg/10mL
Pharmacologic classes Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217415-001 DAPTOMYCIN DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 N217415-002 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217415-001 11759497 2038-08-28 Drug product 2023-10-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 N217415-001 12629337 2043-01-09 Drug product 2026-06-10 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 N217415-002 12629337 2043-01-09 Drug product 2026-06-10
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 · 48 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 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217415-001 DAPTOMYCIN 350MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217415-002 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-01-30 9b2671bbb829…
Observed Orange Book patent history# Patent history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-001 12629337 2043-01-09 Drug product 2026-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217415-002 12629337 2043-01-09 Drug product 2026-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 11759497 2038-08-28 Drug product 2023-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217415-002 12053502 2038-08-28 U-3981 2024-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 11759497 2038-08-28 Drug product 2023-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217415-001 12053502 2038-08-28 U-3981 2024-09-04 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Daptomycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPTOMYCIN 500 mg/10mL
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 72572-158-01 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2 72572-158-01 Daptomycin 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 2
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 72572-158-01 72572015801 1 VIAL, SINGLE-USE in 1 CARTON (72572-158-01) / 10 mL in 1 VIAL, SINGLE-USE 2025-11-28 No No Current