Home NDC 0703-3217 Paclitaxel
Product NDC 0703-3217
11-digit product format 007033217
Labeler code 0703
Product ID 0703-3217_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 2020-03-05
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.
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 2026-08-01 22:54:32 2026-06 A075184-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2002-01-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A075184-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 0703-3217-01 Paclitaxel 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 9 0703-3217-01 Paclitaxel 25 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 25 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-3217 PACLITAXEL INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250502_e4be6cbf-72b9-4f7f-9b1b-459b2d35961a.zip
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 0703-3217-01 00703321701 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3217-01) / 25 mL in 1 VIAL, MULTI-DOSE 2020-03-05 0000-00-00 No No Current