Home NDC 70534-001-00 Paclitaxel
Product NDC 70534-001
Requested package NDC 70534-001-00
11-digit product format 705340001
Labeler code 70534
Product ID 70534-001_0c51fd28-42c2-4584-9c40-91945cd26810
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler HBT Labs, Inc.
Application NDA211875
Marketing category NDA
Marketing start 2022-09-27
Marketing end 0000-00-00
Substance PACLITAXEL
Active strength 100 mg/20mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N211875-001 PACLITAXEL PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N211875-001 AB
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 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 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-07-27 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211875-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2022-07-27 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70534-001-00 70534000100 1 VIAL in 1 CARTON (70534-001-00) > 20 mL in 1 VIAL 1 vial 2022-09-27 0000-00-00 No No Current