BAFIERTAM

Product NDC
69387-001
11-digit product format
693870001
Labeler code
69387
Product ID
69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
monomethyl fumarate
Dosage form
CAPSULE
Route
ORAL
Labeler
Banner Life Sciences LLC
Application
NDA210296
Marketing category
NDA
Marketing start
2020-04-28
Substance
MONOMETHYL FUMARATE
Active strength
95 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BAFIERTAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONOMETHYL FUMARATE95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii45IUB1PX8R
Rxcui2393587, 2393593

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69387-001-01BAFIERTAM120 in 1 BOTTLECAPSULE12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69387-001-01EA - Each69387-0014d18f8c8-e33e-4119-a91f-5102eb74217212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69387-001BAFIERTAM (MONOMETHYL FUMARATE) CAPSULE [BANNER LIFE SCIENCES LLC ]9Current NDC, Legacy NDC, 1 package rows20240517_a161f9d4-70f1-4097-957a-eafb35d3274f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2393593Bafiertam 95 MG Delayed Release Oral CapsulePSNa161f9d4-70f1-4097-957a-eafb35d3274f10
2393587monomethyl fumarate 95 MG Delayed Release Oral CapsulePSNa161f9d4-70f1-4097-957a-eafb35d3274f10
2393593monomethyl fumarate 95 MG Delayed Release Oral Capsule [Bafiertam]SBDa161f9d4-70f1-4097-957a-eafb35d3274f10
2393587monomethyl fumarate 95 MG Delayed Release Oral CapsuleSCDa161f9d4-70f1-4097-957a-eafb35d3274f10
2393593Bafiertam 95 MG Delayed Release Oral CapsuleSYa161f9d4-70f1-4097-957a-eafb35d3274f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69387-001-0169387000101120 CAPSULE in 1 BOTTLE (69387-001-01) 120 capsule2020-04-280000-00-00NoNoCurrent