CellCept

Product NDC
21695-171
11-digit product format
216950171
Labeler code
21695
Product ID
21695-171_23d74606-134c-464c-8323-9cf52bb3c5fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA050722
Marketing category
NDA
Marketing start
1995-05-03
Marketing end
0000-00-00
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-171-002019-09-24C16284748780-1934fe258-4a34-48b1-e053-8cdaa90a720aCellCept ® (mycophenolate mofetil capsules)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-171-00CellCept100 in 1 BOTTLE, PLASTICCAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-171-00EA - Each21695-1713bc63403-df94-48ba-981f-dd1a7499fbc912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mycophenolate MofetilACTIVE INGREDIENT9242ECW6R0CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
mycophenolic acidACTIVE MOIETYHU9DX48N0TCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
Povidone K90INACTIVE INGREDIENTRDH86HJV5ZCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-171CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110525_23d74606-134c-464c-8323-9cf52bb3c5fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616447CellCept 250 MG Oral CapsulePSN23d74606-134c-464c-8323-9cf52bb3c5fa1
199058mycophenolate mofetil 250 MG Oral CapsulePSN23d74606-134c-464c-8323-9cf52bb3c5fa1
616447mycophenolate mofetil 250 MG Oral Capsule [Cellcept]SBD23d74606-134c-464c-8323-9cf52bb3c5fa1
199058mycophenolate mofetil 250 MG Oral CapsuleSCD23d74606-134c-464c-8323-9cf52bb3c5fa1
616447Cellcept (as mycophenolate mofetil) 250 MG Oral CapsuleSY23d74606-134c-464c-8323-9cf52bb3c5fa1
616447Cellcept 250 MG Oral CapsuleSY23d74606-134c-464c-8323-9cf52bb3c5fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-171-0021695017100100 in 1 BOTTLE, PLASTICHistorical