FDA.reportPublic FDA data

100 mg Tablet Bottle Label

Manufacturer
Yunigen, Inc.
Effective date
2026-04-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:13:02

Label at a glance#

ProductSCEDAMIN
Active ingredientHYDROXYUREA
Label structure8 sections

Label contents#

Full prescribing information#

100 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-100-11

100 mg Tablet Bottle Label

SCEDAMIN TM (Hydroxyurea)

100 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25 oC (68-77 oF); excursions

permitted between 15 oC and 30 oC (59 oF and 86 oF)

Protect from moisture.

Manufactured in the United States for Export Only

Distributed by Yunigen Kenya Limited

(See image name: 100mg_bottle) 100 mg Bottle100 mg Bottle

100 mg Tablet Carton Label (1 Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-100-30

SCEDAMINTM (Hydroxyurea)

100 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25oC (68-77oF); excursions

permitted between 15oC and 30oC (59oF and 86oF)

Protect from moisture.

Manufactured in the United States for Export Only

Distributed by Yunigen Kenya Limited

Yunigen, Inc.

(See image name: 100mg_carton_1bottle)

100 mg Carton 1 Bottle100 mg Carton 1 Bottle

100 mg Tablet Blister Label (Back)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-100-21

SCEDAMINTM (Hydroxyurea)

100 mg per Tablet

For Oral Administration

RX Only

For Export Only

Manufactured iby Yunigen, Inc.

Distributed by Yunigen Kenya Limited

B/N:

EXP:

(See image name: 100mg_blister_back)

100 mg Blister Back100 mg Blister Back

100 mg Tablet Carton Label (4 Blisters)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:87500-100-40

SCEDAMIN TM (Hydroxyurea)

100 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25 oC (68-77 oF); excursions

permitted between 15 oC and 30 oC (59 oF and 86 oF)

Protect from moisture.

Export Only

Yunigen, Inc.

LOT:

EXP:

(See image name: 100mg_carton_4blisters)

100 mg Carton 4 Blisters100 mg Carton 4 Blisters

500 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-101-11

SCEDAMIN TM (Hydroxyurea)

500 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25 oC (68-77 oF); excursions

permitted between 15 oC and 30 oC (59 oF and 86 oF)

Protect from moisture.

Manufactured in the United States for Export Only

Distributed by Yunigen Kenya Limited

LOT:

EXP:

(See image name: 500mg_bottle attched)

500 mg Bottle500 mg Bottle

500 mg Tablet Carton Label (1 Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-101-30

SCEDAMIN TM (Hydroxyurea)

500 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25 oC (68-77 oF); excursions

permitted between 15 oC and 30 oC (59 oF and 86 oF)

Protect from moisture.

Lot:

EXP:

Manufactured in the United States for Export Only

Distributed by Yunigen Kenya Limited

(See image name: 500mg_carton_1bottle)

500 mg Carton 1 Bottle500 mg Carton 1 Bottle

500 mg Tablet Blister Label (Back)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-101-20

SCEDAMIN TM (Hydroxyurea)

500 mg per Tablet

For Oral Administration

RX Only

For Export Only

Manufactured by Yunigen, Inc.

Distributed by Yunigen Kenya Limited

B/N:

EXP:

(See image name: 500mg_blister_back)

500 mg Blister Back500 mg Blister Back

500 mg Tablet Carton Label (6 Blisters)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87500-101-41

SCEDAMIN TM (Hydroxyurea)

500 mg per Tablet

For Oral Administration

RX Only

60 Tablets

Store at 20-25 oC (68-77 oF); excursions

permitted between 15 oC and 30 oC (59 oF and 86 oF)

Protect from moisture.

Manufactured in the United States for Export Only

Distributed by Yunigen Kenya Limited

LOT:

EXP:

(See image name: 500mg_carton_6blisters)

500 mg Carton 6 Blisters500 mg Carton 6 Blisters

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1999308hydroxyurea 100 MG Oral TabletPSN2
1999308hydroxyurea 100 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROXYUREA Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)10875000100114(10)AD0010(17)281001GTIN-14: 10875000100114
GTIN storage (14 digits): 10875000100114		500mg_bottle.jpg, 100mg_bottle.jpg
BarcodeData Matrix(01)10875000100213(10)AD0012(17)281205GTIN-14: 10875000100213
GTIN storage (14 digits): 10875000100213		100mg_blister_back.jpg
BarcodeData Matrix(01)10875000101203(10)AF0045(17)281220GTIN-14: 10875000101203
GTIN storage (14 digits): 10875000101203		500mg_carton_6blisters.jpg
BarcodeData Matrix(01)20875000100302(10)AD0010(17)281001GTIN-14: 20875000100302
GTIN storage (14 digits): 20875000100302		100mg_carton_1bottle.jpg
BarcodeData Matrix(01)20875000100401(10)AD0012(17)281001GTIN-14: 20875000100401
GTIN storage (14 digits): 20875000100401		100mg_carton_4blisters.jpg
BarcodeData Matrix(01)20875000101309(10)AF0040(17)281015GTIN-14: 20875000101309
GTIN storage (14 digits): 20875000101309		500mg_carton_1bottle.jpg
BarcodeData Matrix(01)20875000101415(10)AF0045(17)281015GTIN-14: 20875000101415
GTIN storage (14 digits): 20875000101415		500mg_blister_back.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7Product name120250129
f76fb619-09b6-d149-3287-3661f7bc38cdProduct name320250124
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
62a0eedf-9497-47af-bccf-d51b8b15b067Product name120180307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87500-100-11SCEDAMIN60 in 1 BOTTLETABLET, FILM COATED602
87500-100-21SCEDAMIN15 in 1 BLISTER PACKTABLET, FILM COATED152
87500-100-30SCEDAMIN60 in 1 CARTONTABLET, FILM COATED602
87500-100-40SCEDAMIN60 in 1 CARTONTABLET, FILM COATED602
87500-101-11SCEDAMIN60 in 1 BOTTLETABLET, FILM COATED602
87500-101-20SCEDAMIN10 in 1 BLISTER PACKTABLET, FILM COATED102
87500-101-30SCEDAMIN60 in 1 CARTONTABLET, FILM COATED602
87500-101-41SCEDAMIN60 in 1 CARTONTABLET, FILM COATED602

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87500-10087500-100-11, 87500-100-30, 87500-100-21, 87500-100-40
87500-10187500-101-11, 87500-101-30, 87500-101-20, 87500-101-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYDROXYUREAX6Q56QN5QCACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
ISOPROPYL ALCOHOLND2M416302IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
ISOPROPYL ALCOHOLND2M416302IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
HYDROXYUREAX6Q56QN5QCACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4ed45b55-9dca-64fa-e063-6394a90ab09a4dc74ada-f633-3f1a-e063-6394a90a191e2026-04-06Exact identifier
spl id: 4ed45b55-9dca-64fa-e063-6394a90ab09a
spl set id: 4dc74ada-f633-3f1a-e063-6394a90a191e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.