Home NDC 53499-3391 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 Ingredient Strength CYCLAMEN PURPURASCENS TUBER 3 [hp_X]/1 BLACK COHOSH 3 [hp_X]/1 IRIS VERSICOLOR WHOLE 3 [hp_X]/1 GELSEMIUM SEMPERVIRENS WHOLE 4 [hp_X]/1 SANGUINARIA CANADENSIS ROOT 3 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53499-3391-1 Migraide 4 in 1 BOX tablet 4 2 53499-3391-1 Migraide 10 in 1 BLISTER PACK tablet 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-3391 MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20220405_0dc575dd-ef7e-4f91-a2b3-0ea3637a871e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Migraide CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT Schwabe North America, Inc. 0dc575dd-ef7e-4f91-a2b3-0ea3637a871e 2022-03-24 Warnings Exact identifier ndc (product): 53499-3391
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53499-3391-1 53499339101 4 BLISTER PACK in 1 BOX (53499-3391-1) / 10 TABLET in 1 BLISTER PACK 4 blister pack 2021-11-09 2027-01-31 No No Current