Home NDC 0703-4768-81 Paclitaxel
Product NDC 0703-4768
Requested package NDC 0703-4768-81
11-digit product format 007034768
Labeler code 0703
Product ID 0703-4768_0b02547e-0b69-4044-9495-f5b7f287e2c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA075184
Marketing category ANDA
Marketing start 2016-03-03
Marketing end 0000-00-00
Substance PACLITAXEL
Active strength 6 mg/mL
Pharmacologic classes Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 9 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…
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 A075184-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075184-001 AP
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 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-4768-81 00703476881 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4768-81) > 50 mL in 1 VIAL, MULTI-DOSE 2016-03-03 0000-00-00 No No Current