Ergocalciferol (Page 2 of 2)

DOSAGE AND ADMINISTRATION

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

HOW SUPPLIED

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP.

Bottles of 100 Softgel Capsules (NDC 51991-604-01).

Store at 20°– 25°C (68°–77°F) [See USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by: Swiss Caps AG
Kirchberg, Switzerland
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rev. 04/09

PRINCIPAL DISPLAY PANEL — 1.25 mg Bottle Label

Blenheim Pharmacal, Inc.

NDC 10544-527-08

Vitamin D
(Ergocalciferol Capsules, USP)

1.25 mg*

(50,000 USP Units)

Rx Only

8 Softgel Capsules

Label 1.25mg 8ct
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1.25 mg Bottle Label

Blenheim Pharmacal, Inc.

NDC 10544-527-12

Vitamin D
(Ergocalciferol Capsules, USP)

1.25 mg*

(50,000 USP Units)

Rx Only

12 Softgel Capsules

Label 1.25mg 12ct
(click image for full-size original)
ERGOCALCIFEROL
ergocalciferol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-527(NDC:51991-604)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 1.25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
WATER
SOYBEAN OIL
Product Characteristics
Color green Score no score
Shape OVAL Size 13mm
Flavor Imprint Code A3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-527-08 8 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:10544-527-12 12 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040833 10/02/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-527)

Revised: 02/2015 Blenheim Pharmacal, Inc.

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