Home NDC 0703-3213 Paclitaxel
Product NDC 0703-3213
11-digit product format 007033213
Labeler code 0703
Product ID 0703-3213_5d1c9c4b-81d5-4f42-a3c6-34cae431908d
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 2020-07-07
Substance PACLITAXEL
Active strength 6 mg/mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
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 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.
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 0703-3213-01 Paclitaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 9 0703-3213-01 Paclitaxel 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 5 9 0703-3213-81 Paclitaxel 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 5 7 0703-3213-81 Paclitaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-3213 PACLITAXEL INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250502_e4be6cbf-72b9-4f7f-9b1b-459b2d35961a.zip 0703-3213 PACLITAXEL INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250502_fbd32bd2-9685-41cb-bee2-730a45526b65.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-3213-01 00703321301 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSE 2020-07-07 0000-00-00 No No Current 0703-3213-81 00703321381 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE 2020-07-07 0000-00-00 No No Current