Fluorouracil

Product NDC: 68083-270
Requested package NDC: 68083-270-10
11-digit product format: 680830270
Labeler code: 68083
Product ID: 68083-270_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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Application-product, TE code table
Application-product	TE code
A210123-001	AP
A210123-002	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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210123-001	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-10-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210123-002	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-10-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210123-001	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210123-002	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-10-27	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A210123-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210123-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210123-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210123-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210123-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210123-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210123-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210123-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210123-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210123-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210123-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210123-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210123-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210123-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210123-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210123-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210123-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210123-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210123-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210123-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210123-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210123-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210123-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210123-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210123-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210123-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210123-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210123-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210123-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210123-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210123-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210123-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210123-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210123-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210123-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210123-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210123-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210123-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210123-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210123-002	AP	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Fluorouracil
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
572b710e-8e2b-46eb-bd80-648ad769d34d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-270-01	Fluorouracil	20 mL in 1 VIAL	INJECTION, SOLUTION	20		8
68083-270-10	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
68083-270	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOROURACIL	FLUOROURACIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f0b60247-89ff-42b5-a55b-61980c282749	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210123 application number: ANDA210123
Fluorouracil	FLUOROURACIL	Xiromed LLC	19735014-c6fb-0a05-c330-2e9389c71216	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210123 application number: ANDA210123
Fluorouracil	FLUOROURACIL	Gland Pharma Limited	572b710e-8e2b-46eb-bd80-648ad769d34d	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210123 application number: ANDA210123 ndc (package): 68083-270-10 ndc (product): 68083-270 ndc11 (package): 68083027010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791736	fluorouracil 1 GM in 20 ML Injection	PSN	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791701	fluorouracil 500 MG in 10 ML Injection	PSN	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791701	10 ML fluorouracil 50 MG/ML Injection	SCD	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791736	20 ML fluorouracil 50 MG/ML Injection	SCD	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791701	10 ML 5-5-fluorouracil 50 MG/ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791701	10 ML 5-FU 50 MG/ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791736	20 ML 5-5-fluorouracil 50 MG/ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791736	20 ML 5-FU 50 MG/ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791736	fluorouracil 1 GM per 20 ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8
1791701	fluorouracil 500 MG per 10 ML Injection	SY	572b710e-8e2b-46eb-bd80-648ad769d34d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-270-10	68083027010	10 VIAL in 1 CARTON (68083-270-10) / 20 mL in 1 VIAL (68083-270-01)	10 vial	2017-11-07	0000-00-00	No	No	Current