SCEDAMIN- hydroxyurea tablet, film coated

Drug Labeling and Warnings

Drug Details [pdf]

100 mg Tablet Bottle Label

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 Tablet Carton Label (1 Bottle)

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 Tablet Blister Label (Back)

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 Tablet Carton Label (4 Blisters)

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)

500 mg Tablet Bottle Label

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 Tablet Carton Label (1 Bottle)

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 Tablet Blister Label (Back)

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 Tablet Carton Label (6 Blisters)

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)

INGREDIENTS AND APPEARANCE

SCEDAMIN 
hydroxyurea tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87500-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYUREA (UNII: X6Q56QN5QC) (HYDROXYUREA - UNII:X6Q56QN5QC)	HYDROXYUREA	100 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)

Product Characteristics
Color	white (White to Off-white)	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	SCM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87500-100-30	60 in 1 CARTON	05/22/2026
1	NDC: 87500-100-11	60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 87500-100-40	60 in 1 CARTON	05/22/2026
2	NDC: 87500-100-21	15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		04/01/2026

SCEDAMIN 
hydroxyurea tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87500-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYUREA (UNII: X6Q56QN5QC) (HYDROXYUREA - UNII:X6Q56QN5QC)	HYDROXYUREA	500 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (White to off-white)	Score	no score
Shape	OVAL (White to off-white oval shaped tablet with half-scoring on both sides)	Size	16mm
Flavor		Imprint Code	SC;SC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87500-101-30	60 in 1 CARTON	05/22/2026
1	NDC: 87500-101-11	60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 87500-101-41	60 in 1 CARTON	05/22/2026
2	NDC: 87500-101-20	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		04/01/2026

Labeler - Yunigen, Inc. (119379663)

Establishment
Name	Address	ID/FEI	Business Operations
Yunigen, Inc.		119379663	manufacture(87500-100, 87500-101) , analysis(87500-100, 87500-101) , label(87500-100, 87500-101) , pack(87500-100, 87500-101)