Flucytosine

Product NDC: 68151-0084
11-digit product format: 681510084
Labeler code: 68151
Product ID: 68151-0084_82d30146-b669-48d1-b709-a8b38dabfd41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flucytosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA201566
Marketing category: ANDA
Marketing start: 2011-11-03
Marketing end: 0000-00-00
Substance: FLUCYTOSINE
Active strength: 250 mg/1
Pharmacologic classes: Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4cbbebe-6acb-b5dc-a199-fda613aaf07b	Product name	5	20200728

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0084-0	2020-01-31	C162847	48780-1	9d75b9d1-0ed3-f424-e053-dadaa90a57ce	FLUCYTOSINE CAPSULES, USP Rx only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0084-0	Flucytosine	1 in 1 BOTTLE	CAPSULE	1		4

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCYTOSINE	ACTIVE INGREDIENT	D83282DT06	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FLUCYTOSINE	ACTIVE MOIETY	D83282DT06	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0084	FLUCYTOSINE CAPSULE [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_59f0bf8c-21a8-4932-85b2-2fe017a2a486.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D83282DT06	FLUCYTOSINE	2022-85-7	FLUCYTOSINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197702	flucytosine 250 MG Oral Capsule	PSN	59f0bf8c-21a8-4932-85b2-2fe017a2a486	4
197702	flucytosine 250 MG Oral Capsule	SCD	59f0bf8c-21a8-4932-85b2-2fe017a2a486	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0084-0	68151008400	1 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCYTOSINE CAPSULES, USP Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4