Migraide

Product NDC
53499-3391
11-digit product format
534993391
Labeler code
53499
Product ID
53499-3391_bc629508-09ed-4ceb-b954-9dbc2c2d07ab
Type
HUMAN OTC DRUG
Nonproprietary name
CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-11-09
Marketing end
2027-01-31
Substance
BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS WHOLE; IRIS VERSICOLOR WHOLE; SANGUINARIA CANADENSIS ROOT
Active strength
3; 3; 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Migraide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH3 [hp_X]/1
CYCLAMEN PURPURASCENS TUBER3 [hp_X]/1
GELSEMIUM SEMPERVIRENS WHOLE3 [hp_X]/1
IRIS VERSICOLOR WHOLE4 [hp_X]/1
SANGUINARIA CANADENSIS ROOT3 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK73E24S6X9, G728143D8Q, R0519OZO3K, PYC571247P, N9288CD508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3391-1Migraide4 in 1 BOXtablet42
53499-3391-1Migraide10 in 1 BLISTER PACKtablet102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20220405_0dc575dd-ef7e-4f91-a2b3-0ea3637a871e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-3391-1534993391014 BLISTER PACK in 1 BOX (53499-3391-1) / 10 TABLET in 1 BLISTER PACK4 blister pack2021-11-092027-01-31NoNoCurrent