Home NDC 46708-678 Docetaxel
Product NDC 46708-678
11-digit product format 467080678
Labeler code 46708
Product ID 46708-678_682a0b1a-3277-4718-a94e-9645633062bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA215744
Marketing category ANDA
Marketing start 2023-02-28
Substance DOCETAXEL ANHYDROUS
Active strength 10 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215744-001 DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 A215744-002 DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 A215744-003 DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 2 · 69 observed 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 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215744-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215744-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215744-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2023-02-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Docetaxel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCETAXEL ANHYDROUS 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 699121PHCA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1093280 Internal RxNorm lookup 1860619 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 46708-678-02 Docetaxel 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 1 46708-678-02 Docetaxel 1 in 1 CARTON INJECTION 1 1 46708-678-08 Docetaxel 1 in 1 CARTON INJECTION 1 1 46708-678-08 Docetaxel 8 mL in 1 VIAL, MULTI-DOSE INJECTION 8 1 46708-678-16 Docetaxel 16 mL in 1 VIAL, MULTI-DOSE INJECTION 16 1 46708-678-16 Docetaxel 1 in 1 CARTON INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-678 DOCETAXEL INJECTION [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 6 package rows 20230429_682a0b1a-3277-4718-a94e-9645633062bf.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 46708-678-02 46708067802 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE 2023-02-28 No No Current 46708-678-08 46708067808 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 mL in 1 VIAL, MULTI-DOSE 2023-02-28 No No Current 46708-678-16 46708067816 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16) / 16 mL in 1 VIAL, MULTI-DOSE 2023-02-28 No No Current