Home NDC 0009-0082 Camptosar
Product NDC 0009-0082
11-digit product format 000090082
Labeler code 0009
Product ID 0009-0082_6f05fe24-191a-4273-ad62-4ab6b5324062
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name irinotecan hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pharmacia & Upjohn Company LLC
Application NDA020571
Marketing category NDA
Marketing start 2024-06-24
Substance IRINOTECAN HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N020571-001 CAMPTOSAR IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 N020571-002 CAMPTOSAR IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 N020571-003 CAMPTOSAR IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05
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 4 · 123 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 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020571-002 CAMPTOSAR 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020571-003 CAMPTOSAR 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020571-001 CAMPTOSAR 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 1996-06-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Camptosar
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRINOTECAN HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 042LAQ1IIS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726319 Internal RxNorm lookup 1726321 Internal RxNorm lookup 1726324 Internal RxNorm lookup 1726325 Internal RxNorm lookup 1726333 Internal RxNorm lookup 1726335 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 0009-0082-02 Camptosar 1 in 1 CARTON INJECTION, SOLUTION 1 37 0009-0082-02 Camptosar 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 37
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-0082 CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 34 Current NDC, 2 package rows 20250101_e518dfc6-7e93-4fee-a66c-51e1ab71c056.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Camptosar IRINOTECAN HYDROCHLORIDE Pharmacia & Upjohn Company LLC e518dfc6-7e93-4fee-a66c-51e1ab71c056 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020571 application number: NDA020571 ndc (product): 0009-0082
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0009-0082-02 00009008202 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSE 2024-06-24 No No Current