Home NDC 70700-175-22 Docetaxel
Product NDC 70700-175
Requested package NDC 70700-175-22
11-digit product format 707000175
Labeler code 70700
Product ID 70700-175_5b73d1bb-972d-7aca-01d4-7564ef7d1849
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Xiromed LLC
Application ANDA213510
Marketing category ANDA
Marketing start 2021-10-25
Marketing end 0000-00-00
Substance DOCETAXEL ANHYDROUS
Active strength 10 mg/mL
Pharmacologic classes Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 A213510-001 DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 A213510-002 DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 A213510-003 DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01
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 3 · 99 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 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213510-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213510-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213510-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2021-07-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70700-175-22 70700017522 1 VIAL, MULTI-DOSE in 1 CARTON (70700-175-22) > 8 mL in 1 VIAL, MULTI-DOSE 2021-10-25 0000-00-00 No No Current