Carac

Product NDC: 0187-5200
11-digit product format: 001875200
Labeler code: 0187
Product ID: 0187-5200_e2893139-8c8c-4af0-8022-b717e6eaa783
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluorouracil
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA020985
Marketing category: NDA
Marketing start: 2013-06-28
Marketing end: 0000-00-00
Substance: FLUOROURACIL
Active strength: 5 mg/g
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0187-5200		D	Discontinued by firm		2026-08-10
excluded package	package	0187-5200	0187-5200-30	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5200-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5200-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5200-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5200-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5200-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5200-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5200-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5200-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5200-30	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020985-001	CARAC	FLUOROURACIL	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27

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 · 41 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	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020985-001	CARAC	0.5%	CREAM / TOPICAL	AB	RLD, RS	2000-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020985-001	CARAC	0.5%	CREAM / TOPICAL		RLD, RS	2000-10-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020985-001	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020985-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020985-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020985-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020985-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020985-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020985-001	6670335	2021-06-02	U-68	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020985-001	6670335	2021-06-02	U-68	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020985-001	6670335	2021-06-02	U-68	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020985-001	6670335	2021-06-02	U-68	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020985-001	6670335	2021-06-02	U-68	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020985-001	6670335	2021-06-02	U-68	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020985-001	6670335	2021-06-02	U-68	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020985-001	6670335	2021-06-02	U-68	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020985-001	6670335	2021-06-02	U-68	Drug product	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5200-30	GM - Gram	0187-5200	b73725cb-b1b4-40df-ba86-e0090ceeec10	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
fluorouracil	ACTIVE INGREDIENT	U3P01618RT	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
fluorouracil	ACTIVE MOIETY	U3P01618RT	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
ETHYLHEXYL HYDROXYSTEARATE	INACTIVE INGREDIENT	B7I80BVV5E	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
methyl gluceth-20	INACTIVE INGREDIENT	J3QD0LD11P	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER	INACTIVE INGREDIENT	EG97988M5Q	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
sorbitan monooleate	INACTIVE INGREDIENT	06XEA2VD56	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
water	INACTIVE INGREDIENT	059QF0KO0R	CARAC (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

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
FLUOROURACIL	FLUOROURACIL CREAM, 0.5%	Dr. Reddy's Laboratories Inc.	37dcfb83-0e7d-d23d-9cd5-afa5bdc30628	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020985 application number: NDA020985

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5200-30	00187520030	1 TUBE in 1 CARTON (0187-5200-30) > 30 g in 1 TUBE	1 tube	2013-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carac ® Cream, 0.5% (fluorouracil cream)	Bausch Health US, LLC \| Bausch Health Companies Inc.	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	10