Home NDC 68083-269 Fluorouracil
Product NDC 68083-269
11-digit product format 680830269
Labeler code 68083
Product ID 68083-269_0e5faa31-6fd8-49b5-b838-1278cf068666
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorouracil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA210123
Marketing category ANDA
Marketing start 2017-11-07
Substance FLUOROURACIL
Active strength 50 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210123-001 FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 A210123-002 FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210123-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210123-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2017-10-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluorouracil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROURACIL 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3P01618RT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791701 Internal RxNorm lookup 1791736 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 68083-269-01 Fluorouracil 10 mL in 1 VIAL INJECTION, SOLUTION 10 8 68083-269-10 Fluorouracil 10 in 1 CARTON INJECTION, SOLUTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-269 FLUOROURACIL INJECTION, SOLUTION [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20240229_572b710e-8e2b-46eb-bd80-648ad769d34d.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 Units Marketing start Marketing end Sample Exclude flag Status 68083-269-01 68083026901 10 mL in 1 VIAL 10 ml Historical 68083-269-10 68083026910 10 VIAL in 1 CARTON (68083-269-10) / 10 mL in 1 VIAL (68083-269-01) 10 vial 2017-11-07 0000-00-00 No No Current