Home NDC 0338-0714 Daptomycin in Sodium Chloride
Product NDC 0338-0714
11-digit product format 003380714
Labeler code 0338
Product ID 0338-0714_42d6b08e-92f7-433d-b695-7037493ec2e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daptomycin in Sodium Chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA213645
Marketing category NDA
Marketing start 2022-01-25
Substance DAPTOMYCIN
Active strength 500 mg/50mL
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 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213645-001 DAPZURA RT DAPTOMYCIN 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE DAPTOMYCIN 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE DAPTOMYCIN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE DAPTOMYCIN 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE DAPTOMYCIN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28
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 4 · 139 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 2026-10-15 13:18:30 2026-09 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-001 DAPZURA RT 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2022-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-002 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 350MG/50ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-003 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-004 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 700MG/100ML (7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-005 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-27 b8a1b40f171c…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213645-001 11173189 2041-03-11 U-3294 Drug product 2022-01-28 a50c72e98297…
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 in Sodium Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAPTOMYCIN 500 mg/50mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0714-24 Daptomycin in Sodium Chloride 50 mL in 1 BAG INJECTION, SOLUTION 50 10 0338-0714-24 Daptomycin in Sodium Chloride 24 in 1 CARTON INJECTION, SOLUTION 24 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0714 DAPTOMYCIN IN SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 9 Current NDC, 2 package rows 20250508_7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DAPZURA RT DAPTOMYCIN Baxter Healthcare Corporation cb1283e1-35b8-425c-b338-d9ac0c7161f8 2022-01-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 213645 application number: NDA213645
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0338-0714-24 00338071424 24 BAG in 1 CARTON (0338-0714-24) / 50 mL in 1 BAG 24 bag 2023-02-27 No No Current