Home NDC 46708-621 Paclitaxel
Product NDC 46708-621
11-digit product format 467080621
Labeler code 46708
Product ID 46708-621_6d04b514-c85c-4db1-919e-21dd98172791
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA216874
Marketing category ANDA
Marketing start 2022-10-20
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 A216874-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216874-001 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 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216874-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2022-10-20 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 46708-621-17 Paclitaxel 1 in 1 CARTON INJECTION 1 1 46708-621-17 Paclitaxel 16.7 mL in 1 VIAL, MULTI-DOSE INJECTION 16.7 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-621 PACLITAXEL INJECTION [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20230201_6d04b514-c85c-4db1-919e-21dd98172791.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 · 3 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 46708-621-17 46708062117 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 16.7 mL in 1 VIAL, MULTI-DOSE 2022-10-20 No No Current