FDA.reportPublic FDA data

DAPZURA RT

Product NDC
60977-145
Requested package NDC
60977-145-01
11-digit product format
609770145
Labeler code
60977
Product ID
60977-145_b5b302e0-d9e2-4032-ae95-cad85b08e130
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA213645
Marketing category
NDA
Marketing start
2022-01-25
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60977-14560977-145-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213645-001DAPZURA RTDAPTOMYCIN500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD2022-01-25
N213645-002DAPTOMYCIN IN 0.9% SODIUM CHLORIDEDAPTOMYCIN350MG/50ML (7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27
N213645-003DAPTOMYCIN IN 0.9% SODIUM CHLORIDEDAPTOMYCIN500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27
N213645-004DAPTOMYCIN IN 0.9% SODIUM CHLORIDEDAPTOMYCIN700MG/100ML (7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27
N213645-005DAPTOMYCIN IN 0.9% SODIUM CHLORIDEDAPTOMYCIN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213645-001111731892041-03-11U-3294Drug product2022-01-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N213645-001DAPZURA RT500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD2022-01-25a50c72e98297…
2026-08-01 22:54:322026-06N213645-002DAPTOMYCIN IN 0.9% SODIUM CHLORIDE350MG/50ML (7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27a50c72e98297…
2026-08-01 22:54:322026-06N213645-003DAPTOMYCIN IN 0.9% SODIUM CHLORIDE500MG/50ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27a50c72e98297…
2026-08-01 22:54:322026-06N213645-004DAPTOMYCIN IN 0.9% SODIUM CHLORIDE700MG/100ML (7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27a50c72e98297…
2026-08-01 22:54:322026-06N213645-005DAPTOMYCIN IN 0.9% SODIUM CHLORIDE1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-02-27a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N213645-001111731892041-03-11U-3294Drug product2022-01-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daptomycin in Sodium ChlorideDAPTOMYCIN IN SODIUM CHLORIDEBaxter Healthcare Corporation7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef2025-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 213645
application number: NDA213645
DAPZURA RTDAPTOMYCINBaxter Healthcare Corporationcb1283e1-35b8-425c-b338-d9ac0c7161f82022-01-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 213645
application number: NDA213645
ndc (package): 60977-145-01
ndc (product): 60977-145
ndc11 (package): 60977014501

Additional Listing Data#

Finished product
Yes
Brand name base
DAPZURA RT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN500 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NWQ5N31VKKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403920Internal RxNorm lookup
2591793Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb1283e1-35b8-425c-b338-d9ac0c7161f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151aProduct name120250724
223d8260-7a4e-4ebd-9635-845422d6a8adProduct name920240909
ca803a62-3799-476f-bbc6-024f77cb0320Product name420240207
cad85d83-8fb9-49f8-a5a6-a399af412964Product name120230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7Product name120230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703Product name120220929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60977-145-01DAPZURA RT1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
60977-145-01DAPZURA RT10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60977-145DAPZURA RT (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20250302_cb1283e1-35b8-425c-b338-d9ac0c7161f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSNcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793Dapzura 500 MG InjectionPSNcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793daptomycin 500 MG Injection [Dapzura]SBDcb1283e1-35b8-425c-b338-d9ac0c7161f87
403920daptomycin 500 MG InjectionSCDcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793Dapzura 500 MG InjectionSYcb1283e1-35b8-425c-b338-d9ac0c7161f87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60977-145-01609770145011 VIAL in 1 CARTON (60977-145-01) > 10 mL in 1 VIAL1 vial2022-01-250000-00-00NoNoCurrent