FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
31722-878
11-digit product format
317220878
Labeler code
31722
Product ID
31722-878_3b604c8c-672d-7b1e-e063-6394a90a255f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA207022
Marketing category
ANDA
Marketing start
2024-10-22
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 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
IngredientStrength
MYCOPHENOLATE MOFETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui199058

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-878-01Mycophenolate Mofetil1 in 1 CARTONCAPSULE13
31722-878-01Mycophenolate Mofetil100 in 1 BOTTLECAPSULE1003
31722-878-05Mycophenolate Mofetil500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-878-01EA - Each31722-878c0d39872-43d5-4b81-91ed-6216fab28b3712025-03-04
31722-878-05EA - Each31722-878a12c575b-a8e7-4d53-b29a-2a1b6be5952d12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-878MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) CAPSULE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20250110_118e9bc8-c1a9-41d0-89e6-251f3be0b99c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199058mycophenolate mofetil 250 MG Oral CapsulePSN118e9bc8-c1a9-41d0-89e6-251f3be0b99c3
199058mycophenolate mofetil 250 MG Oral CapsuleSCD118e9bc8-c1a9-41d0-89e6-251f3be0b99c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-878-01317220878011 BOTTLE in 1 CARTON (31722-878-01) / 100 CAPSULE in 1 BOTTLE1 bottle2024-10-22NoNoCurrent
31722-878-0531722087805500 CAPSULE in 1 BOTTLE (31722-878-05) 500 capsule2024-12-12NoNoCurrent