Home NDC 72485-212-05 Irinotecan Hydrochloride
Product NDC 72485-212
Requested package NDC 72485-212-05
11-digit product format 724850212
Labeler code 72485
Product ID 72485-212_e1309129-c950-48ba-b8af-a952d5b3bed3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Armas Pharmaceuticals Inc.
Application ANDA208718
Marketing category ANDA
Marketing start 2019-04-01
Substance IRINOTECAN HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
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 A208718-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 A208718-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 A208718-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16
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 · 119 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 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208718-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208718-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2019-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208718-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2018-12-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 119 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72485-212-05 Irinotecan Hydrochloride100 mg/5 mL 5 mL in 1 VIAL INJECTION 5 2 72485-212-05 Irinotecan Hydrochloride100 mg/5 mL 1 in 1 CARTON INJECTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-212 IRINOTECAN HYDROCHLORIDE 100 MG/5 ML (IRINOTECAN HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20200908_2f160344-4ec6-4285-b293-86c0dd40d8b5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72485-212-05 72485021205 1 VIAL in 1 CARTON (72485-212-05) / 5 mL in 1 VIAL 1 vial 2019-04-01 0000-00-00 No No Current