Mycophenolate mofetil

Product NDC: 60687-438
11-digit product format: 606870438
Labeler code: 60687
Product ID: 60687-438_45762f11-5cf6-b346-e063-6394a90a6199
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mycophenolate Mofetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA090456
Marketing category: ANDA
Marketing start: 2019-06-14
Substance: MYCOPHENOLATE MOFETIL
Active strength: 500 mg/1
Pharmacologic classes: Antimetabolite Immunosuppressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Mycophenolate mofetil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MYCOPHENOLATE MOFETIL	500 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	9242ECW6R0
Rxcui	200060

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04b26d3d-97dc-48db-824b-10b299945382	Product name	8	20250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4b	Product name	1	20250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3	Product name	9	20210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-438-01	Mycophenolate mofetil	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		7
60687-438-11	Mycophenolate mofetil	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-438-01	EA - Each	60687-438	aec17686-cf31-4c25-ac78-74399bc66647	1	2019-07-02
60687-438-11	EA - Each	60687-438	a3365588-0d61-44d4-bb21-000307120d84	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-438	MYCOPHENOLATE MOFETIL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	6	Current NDC, Legacy NDC, 2 package rows	20241115_8015f042-54fb-4a7a-a10b-6219e1a450c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200060	mycophenolate mofetil 500 MG Oral Tablet	PSN	8015f042-54fb-4a7a-a10b-6219e1a450c8	7
200060	mycophenolate mofetil 500 MG Oral Tablet	SCD	8015f042-54fb-4a7a-a10b-6219e1a450c8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-438-01	60687043801	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11)	100 blister pack	2019-06-14	0000-00-00	No	No	Current
60687-438-11	60687043811	1 in 1 BLISTER PACK						Historical