NDC 67184-0549-01 - Daptomycin
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 67184-0549
- Requested NDC
- 67184-0549-01
- Package NDCs from labels
- 67184-0549-1, 67184-0549-01
- Manufacturer
- Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
- Effective date
- 2025-06-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Daptomycin | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd. | 2025-06-16 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67184-0549-1 | Daptomycin | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 10 | 6 | |
| 67184-0549-1 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67184-0549 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20211118_e32c7141-fbd9-47c8-bd1e-94b880b2c5a6.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Daptomycin | DAPTOMYCIN | Biocon Pharma Inc. | 914d4040-eb29-cda5-75e9-95060aa4fe6d | 2025-08-29 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| daptomycin | DAPTOMYCIN | BE Pharmaceuticals Inc. | c305bc9f-8aeb-40de-8492-154929764daf | 2025-08-29 | Warnings, Adverse reactions | NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Par Health USA, LLC | c1d47001-5e0f-46a3-b220-53f46b4fd6ac | 2025-08-19 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| daptomycin | DAPTOMYCIN | Mylan Institutional LLC | 95909792-972b-4c0c-b2ce-2be4bed36cff | 2025-08-15 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Hikma Pharmaceuticals USA Inc. | 6aa6300a-f59b-4260-b021-8a02cfaeabb7 | 2025-07-30 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | MAIA Pharmaceuticals, Inc. | d87bd6b5-bf92-49c1-879b-dc2add3deae6 | 2025-07-16 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Dr.Reddy's Laboratories Inc., | 7e9a1b82-f2ba-b2a4-619c-bea7768263e1 | 2025-06-30 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Qilu Pharmaceutical Co., Ltd. | e32c7141-fbd9-47c8-bd1e-94b880b2c5a6 | 2025-06-16 | Warnings, Adverse reactions | ANDA215316 67184-0549-1 67184-0549 67184054901 403920 77549b99-ead5-4148-a1b1-e1b66e9da5ea e32c7141-fbd9-47c8-bd1e-94b880b2c5a6 NWQ5N31VKK |
| daptomycin | DAPTOMYCIN | Sintetica US LLC | 0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3 | 2025-02-07 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Xellia Pharmaceuticals USA LLC | 5e1f739a-eb81-43d8-9a14-89f32b7e1ba1 | 2024-05-24 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Xellia Pharmaceuticals USA LLC | 97c47c18-985d-4373-88f7-a86ec591ea44 | 2024-04-08 | Warnings, Adverse reactions | NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Civica, Inc. | bcacf746-a3ee-48b5-bfbe-6a2b548ad24c | 2024-04-05 | Warnings, Adverse reactions | NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | APOTEX CORP. | 4bf6cd85-dfc8-44d4-b569-3ff27b9d3c09 | 2024-01-19 | Warnings, Adverse reactions | ANDA215316 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Xellia Pharmaceuticals USA LLC | 494b2aa1-020b-432c-977e-a5d74e31e342 | 2023-11-17 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| daptomycin | DAPTOMYCIN | Hainan Poly Pharm., Co., Ltd. | 6ec53f7e-9a5f-4b24-84e9-c94325750e32 | 2023-11-14 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Civica, Inc. | b1569dbe-7876-481e-bc1c-9c9dd85c4973 | 2023-11-13 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| DAPTOMYCIN | DAPTOMYCIN | Eugia US LLC | 353bfcaa-a0ff-47ab-829a-35ca340f6a08 | 2023-09-25 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Xellia Pharmaceuticals USA LLC | fc7eef03-042b-44a1-a344-1fa8a0435900 | 2023-08-04 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | NorthStar RxLLC | 01f3f32a-fac1-4a8f-b205-4601046f0b5c | 2023-04-19 | Warnings, Adverse reactions | NWQ5N31VKK |
| Daptomycin | DAPTOMYCIN | Fresenius Kabi USA, LLC | fa514937-e025-4ea7-b62a-385eb056ae70 | 2022-11-30 | Warnings, Adverse reactions | 403920 NWQ5N31VKK |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.