FDA.reportPublic FDA data

Daptomycin

Product NDC
70511-182
Requested package NDC
70511-182-84
11-digit product format
705110182
Labeler code
70511
Product ID
70511-182_2be7556c-17a9-47ff-82bd-0b1b3316b6a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
MAIA Pharmaceuticals, Inc.
Application
NDA217630
Marketing category
NDA
Marketing start
2025-09-08
Substance
DAPTOMYCIN
Active strength
500 mg/1
Pharmacologic classes
Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217630-001DAPTOMYCINDAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-21
N217630-002DAPTOMYCINDAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21

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
2026-09-14 22:38:342026-08N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-2184e616aacf4f…
2026-09-14 22:38:342026-08N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2184e616aacf4f…
2026-08-18 06:07:402026-07N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-212680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217630-001DAPTOMYCIN350MG/VIALPOWDER / INTRAVENOUSRLD2024-11-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217630-002DAPTOMYCIN500MG/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-21a50c72e98297…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN500 mg/1

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
1996246Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d87bd6b5-bf92-49c1-879b-dc2add3deae6Available 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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaptomycinDAPTOMYCINPar Health USA, LLCc1d47001-5e0f-46a3-b220-53f46b4fd6ac2025-08-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 217630
application number: NDA217630
DaptomycinDAPTOMYCINMAIA Pharmaceuticals, Inc.d87bd6b5-bf92-49c1-879b-dc2add3deae62025-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 217630
application number: NDA217630
ndc (package): 70511-182-84
ndc (product): 70511-182
ndc11 (package): 70511018284

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSNd87bd6b5-bf92-49c1-879b-dc2add3deae63
403920DAPTOmycin 500 MG InjectionPSNd87bd6b5-bf92-49c1-879b-dc2add3deae63
1996246daptomycin 350 MG InjectionSCDd87bd6b5-bf92-49c1-879b-dc2add3deae63
403920daptomycin 500 MG InjectionSCDd87bd6b5-bf92-49c1-879b-dc2add3deae63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70511-182-847051101828410 VIAL, SINGLE-DOSE in 1 CARTON (70511-182-84) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-182-15) 2025-09-08NoNoCurrent