FDA.reportPublic FDA data

Paclitaxel

Product NDC
75007-041
11-digit product format
750070041
Labeler code
75007
Product ID
75007-041_83b2ce8a-e9d2-4227-94fd-7edf4f942cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel (aibumin-bound)
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Ningbo Shuangcheng Pharmaceutical Co., Ltd
Application
ANDA216355
Marketing category
ANDA
Marketing start
2025-05-15
Substance
PACLITAXEL
Active strength
100 mg/100mg
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216355-001PACLITAXELPACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216355-001AB

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
2026-10-15 13:18:302026-09A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-15c2088c7a36db…
2026-09-14 22:38:342026-08A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-1584e616aacf4f…
2026-08-18 06:07:402026-07A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216355-001PACLITAXEL100MG/VIALPOWDER / INTRAVENOUSAB2025-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A216355-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A216355-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A216355-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216355-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216355-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216355-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216355-001AB1a50c72e98297…

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
Paclitaxel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACLITAXEL100 mg/100mg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfd8626-d4ce-43ae-acb3-8de37f80302fProduct name320260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94Product name520240102
a05831c4-07a7-44ad-9dc5-89391450ee82Product name120230323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75007-041-01Paclitaxel1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
75007-041-01Paclitaxel100 mg in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1005

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PaclitaxelPACLITAXEL (AIBUMIN-BOUND)Ningbo Shuangcheng Pharmaceutical Co., Ltd4df3fda6-0b29-420e-ab91-81441ce914ed2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216355
application number: ANDA216355
ndc (product): 75007-041
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELNorthStar Rx LLC1e9d5093-fbfc-470a-8520-811c46a8870c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216355
application number: ANDA216355
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELBluePoint Laboratories36d4a2ed-4b34-4b06-e063-6394a90acc862025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216355
application number: ANDA216355
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELMeitheal Pharmaceuticals Inc.31e893aa-8d9e-4576-8614-eb2fe772bde42025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216355
application number: ANDA216355

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583214PACLitaxel 100 MG InjectionPSN4df3fda6-0b29-420e-ab91-81441ce914ed5
583214paclitaxel 100 MG InjectionSCD4df3fda6-0b29-420e-ab91-81441ce914ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75007-041-01750070041011 in 1 CARTONHistorical