Home NDC 16714-137 Paclitaxel
Product NDC 16714-137
11-digit product format 167140137
Labeler code 16714
Product ID 16714-137_1f5ca3d3-f137-4efe-91d1-11fac6e8ebb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Northstar Rx LLC
Application ANDA213434
Marketing category ANDA
Marketing start 2021-01-25
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 A213434-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213434-001 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.
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 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213434-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2020-08-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Paclitaxel
Listing expiration 2026-12-31 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 16714-137-01 Paclitaxel 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 2 16714-137-01 Paclitaxel 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-137 PACLITAXEL INJECTION, SOLUTION [NORTHSTAR RX LLC] 2 Current NDC, Legacy NDC, 2 package rows 20210728_e47c2c34-0466-4219-be6f-97e4231ed55f.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Paclitaxel PACLITAXEL Bryant Ranch Prepack 30384708-1fcd-4a75-94d7-9d5d617a37b6 2026-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213434 application number: ANDA213434 Paclitaxel PACLITAXEL BluePoint Laboratories 9e7bc2c2-a369-4c6f-9dd9-ee98ddaae833 2025-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213434 application number: ANDA213434 Paclitaxel PACLITAXEL Northstar Rx LLC e47c2c34-0466-4219-be6f-97e4231ed55f 2021-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213434 application number: ANDA213434 ndc (product): 16714-137 Paclitaxel PACLITAXEL Novadoz Pharmaceuticals LLC 4e1bf850-d616-4ff3-b62a-2057dddc3dfe 2020-08-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213434 application number: ANDA213434
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 16714-137-01 16714013701 1 VIAL, MULTI-DOSE in 1 CARTON (16714-137-01) / 50 mL in 1 VIAL, MULTI-DOSE 2021-01-25 0000-00-00 No No Current