Home NDC 71288-183 Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Product NDC 71288-183
11-digit product format 712880183
Labeler code 71288
Product ID 71288-183_ab2be690-a801-46c1-a254-213c3893fc24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA216355
Marketing category ANDA
Marketing start 2025-05-15
Substance PACLITAXEL
Active strength 100 mg/20mL
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 43 .
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 A216355-001 PACLITAXEL PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216355-001 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 2026-09-14 22:38:34 2026-08 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216355-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-05-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PACLITAXEL 100 mg/20mL
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 583214 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 71288-183-50 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 71288-183-50 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-183 PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20250524_31e893aa-8d9e-4576-8614-eb2fe772bde4.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 (AIBUMIN-BOUND) Ningbo Shuangcheng Pharmaceutical Co., Ltd 4df3fda6-0b29-420e-ab91-81441ce914ed 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216355 application number: ANDA216355 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) PACLITAXEL NorthStar Rx LLC 1e9d5093-fbfc-470a-8520-811c46a8870c 2025-09-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216355 application number: ANDA216355 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) PACLITAXEL BluePoint Laboratories 36d4a2ed-4b34-4b06-e063-6394a90acc86 2025-08-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216355 application number: ANDA216355 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) PACLITAXEL Meitheal Pharmaceuticals Inc. 31e893aa-8d9e-4576-8614-eb2fe772bde4 2025-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216355 application number: ANDA216355 ndc (product): 71288-183
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71288-183-50 71288018350 1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50) / 20 mL in 1 VIAL, SINGLE-USE 2025-05-15 No No Current