Home NDC 63323-104 Etoposide
Product NDC 63323-104
11-digit product format 633230104
Labeler code 63323
Product ID 63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETOPOSIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA074983
Marketing category ANDA
Marketing start 2001-07-18
Substance ETOPOSIDE
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 42 .
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 A074983-001 ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074983-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074983-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP RS 1998-09-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Etoposide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETOPOSIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6PLQ3CP4P3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310248 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 63323-104-01 Etoposide 1 in 1 BOX INJECTION, SOLUTION 1 6 63323-104-01 Etoposide 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 6 63323-104-05 Etoposide 10 in 1 CARTON INJECTION, SOLUTION 10 6 63323-104-06 Etoposide 1 in 1 CARTON INJECTION, SOLUTION 1 6 63323-104-06 Etoposide 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 6 63323-104-25 Etoposide 25 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 25 6 63323-104-25 Etoposide 1 in 1 CARTON INJECTION, SOLUTION 1 6 63323-104-50 Etoposide 1 in 1 CARTON INJECTION, SOLUTION 1 6 63323-104-50 Etoposide 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETOPOSIDE ACTIVE INGREDIENT 6PLQ3CP4P3 ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 ETOPOSIDE ACTIVE MOIETY 6PLQ3CP4P3 ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-104 ETOPOSIDE (ETOPOSIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 9 package rows 20220612_fe870629-104d-4d67-a7c6-f53bc588121e.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.
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 63323-104-01 63323010401 1 in 1 BOX Historical 63323-104-05 63323010405 10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE 10 box 2001-07-18 0000-00-00 No No Current 63323-104-06 63323010406 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE 2022-09-09 0000-00-00 No No Current 63323-104-25 63323010425 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSE 2001-07-18 0000-00-00 No No Current 63323-104-50 63323010450 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 mL in 1 VIAL, MULTI-DOSE 2001-07-18 0000-00-00 No No Current