Home NDC 69097-398 Paclitaxel protein-bound particles
Product NDC 69097-398
11-digit product format 690970398
Labeler code 69097
Product ID 69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel protein-bound particles
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application ANDA209657
Marketing category ANDA
Marketing start 2025-04-15
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 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 A209657-001 PACLITAXEL PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209657-001 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 A209657-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209657-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209657-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-04-10 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209657-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB 2025-04-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209657-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209657-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209657-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209657-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Paclitaxel protein-bound particles
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 69097-398-78 Paclitaxel protein-bound particles 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 2 69097-398-78 Paclitaxel protein-bound particles 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-398 PACLITAXEL PROTEIN-BOUND PARTICLES INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [CIPLA USA INC.] 2 Current NDC, 2 package rows 20250417_15eba86c-d9de-42e6-bc95-70ba4c015e72.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69097-398-78 69097039878 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE 2025-04-15 No No Current