Home NDC 69339-229 Paclitaxel
Product NDC 69339-229
11-digit product format 693390229
Labeler code 69339
Product ID 69339-229_3adcb50c-5c38-4e6b-91f9-a776b843ed47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Natco Pharma USA LLC
Application ANDA091540
Marketing category ANDA
Marketing start 2024-11-07
Substance PACLITAXEL
Active strength 6 mg/mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69339-229-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69339-229-05 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69339-229-05 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69339-229-05 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69339-229-05 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69339-229-05 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091540-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Paclitaxel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PACLITAXEL 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P88XT4IS4D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312199 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69339-229-50 Paclitaxel 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 3 69339-229-50 Paclitaxel 1 in 1 CARTON INJECTION, SOLUTION 1 3
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69339-229-50 69339022950 1 VIAL, MULTI-DOSE in 1 CARTON (69339-229-50) / 50 mL in 1 VIAL, MULTI-DOSE 2024-11-07 No No Current