Home NDC 72201-1009 Daptomycin
Product NDC 72201-1009
11-digit product format 722011009
Labeler code 72201
Product ID 72201-1009_59ed32d6-bf21-6804-e063-6394a90a06c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Aspiro Pharma Limited
Application ANDA216413
Marketing category ANDA
Marketing start 2022-09-23
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72201-1009-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72201-1009-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72201-1009-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72201-1009-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72201-1009-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72201-1009-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72201-1009-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72201-1009-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72201-1009-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216413-001 DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216413-001 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 2026-09-14 22:38:34 2026-08 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216413-001 DAPTOMYCIN 500MG/VIAL INJECTABLE / INJECTION AP 2022-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216413-001 DAPTOMYCIN 500MG/VIAL INJECTABLE / INJECTION AP 2022-09-23 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216413-001 DAPTOMYCIN 500MG/VIAL POWDER / INTRAVENOUS AP 2022-09-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72201-1009-0 Daptomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 72201-1009-0 Daptomycin 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72201-1009 DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASPIRO PHARMA LIMITED] 1 Current NDC, 2 package rows 20230506_e6fef9de-e357-4fa3-8839-f483edf1b4d0.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 Marketing start Sample Exclude flag Status 72201-1009-0 72201100900 1 VIAL, SINGLE-DOSE in 1 CARTON (72201-1009-0) / 10 mL in 1 VIAL, SINGLE-DOSE 2022-09-23 No No Current