FDA.reportPublic FDA data

NDC 70511-182-15 - 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
70511-182
Requested NDC
70511-182-15
Package NDCs from labels
70511-182-15, 70511-182-84
Manufacturer
MAIA Pharmaceuticals, Inc. | Gland Pharma Limited
Effective date
2025-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Daptomycin - MAIA Pharmaceuticals, Inc. | Gland Pharma LimitedMAIA Pharmaceuticals, Inc. | Gland Pharma Limited2025-07-16Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70511-182-15Daptomycin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13
70511-182-84Daptomycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70511-182DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250402_d87bd6b5-bf92-49c1-879b-dc2add3deae6.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 2 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaptomycinDAPTOMYCINHikma Pharmaceuticals USA Inc.74176769-b22e-4e41-8c56-051e15ec5fea2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 403920
rxcui: 1996246
unii: NWQ5N31VKK
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.4f39cddc-1cb7-41d4-a657-07f7903ee24f2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 1996246
unii: NWQ5N31VKK
daptomycinDAPTOMYCINBE Pharmaceuticals Inc.4cdf4099-db58-43b8-9fbc-afd997ccfa4b2025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DAPTOMYCINDAPTOMYCINAccord Healthcare Inc.956b068f-5958-49eb-9c9f-3b6e324e77d22025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINAccord Healthcare, Inc.f69e9306-ffac-41c9-b277-a6d784f2e3412025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 1996246
unii: NWQ5N31VKK
DAPTOMYCINDAPTOMYCINMeitheal Pharmaceuticals Inc.7d50f20e-5e26-4cc0-ae45-830df5a46a422025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
daptomycinDAPTOMYCINMylan Institutional LLCb7737862-e783-4af3-9521-ae00ed7a42aa2025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINBiocon Pharma Inc.914d4040-eb29-cda5-75e9-95060aa4fe6d2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
daptomycinDAPTOMYCINBE Pharmaceuticals Inc.c305bc9f-8aeb-40de-8492-154929764daf2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 1996246
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINPar Health USA, LLCc1d47001-5e0f-46a3-b220-53f46b4fd6ac2025-08-19Warnings, Adverse reactionsExact identifier
application number: NDA217630
rxcui: 403920
unii: NWQ5N31VKK
daptomycinDAPTOMYCINMylan Institutional LLC95909792-972b-4c0c-b2ce-2be4bed36cff2025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINHikma Pharmaceuticals USA Inc.6aa6300a-f59b-4260-b021-8a02cfaeabb72025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINMAIA Pharmaceuticals, Inc.d87bd6b5-bf92-49c1-879b-dc2add3deae62025-07-16Warnings, Adverse reactionsExact identifier
application number: NDA217630
ndc (package): 70511-181-10
ndc (package): 70511-182-15
ndc (package): 70511-182-84
ndc (package): 70511-181-84
ndc (product): 70511-181
ndc (product): 70511-182
ndc11 (package): 70511018215
rxcui: 403920
rxcui: 1996246
spl id: 2be7556c-17a9-47ff-82bd-0b1b3316b6a1
spl set id: d87bd6b5-bf92-49c1-879b-dc2add3deae6
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINDr.Reddy's Laboratories Inc.,7e9a1b82-f2ba-b2a4-619c-bea7768263e12025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
DaptomycinDAPTOMYCINQilu Pharmaceutical Co., Ltd.e32c7141-fbd9-47c8-bd1e-94b880b2c5a62025-06-16Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
daptomycinDAPTOMYCINSintetica US LLC0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e32025-02-07Warnings, Adverse reactionsExact identifier
rxcui: 403920
unii: NWQ5N31VKK
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.