PREMARIN Film-coated tablet Ref.[10602] Active ingredients: Estrogens, conjugated

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

PREMARIN (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of conjugated estrogens.

PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:

Tablet strength Tablet color contains
0.3 mg D&C Yellow No. 10 and FD&C Blue No. 2
0.45 mg FD&C Blue No. 2
0.625 mg FD&C Blue No. 2 and FD&C Red No. 40
0.9 mg D&C Red No. 30 and D&C Red No. 7
1.25 mg Black iron oxide, D&C Yellow No. 10 and FD&C Yellow No. 6

PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below:

PREMARIN 1.25 mg tablets USP Dissolution Test 4
PREMARIN 0.3 mg, 0.45 mg and 0.625 mg tablets USP Dissolution Test 5
PREMARIN 0.9 mg tablets USP Dissolution Test 6
Dosage Forms and Strengths

PREMARIN (conjugated estrogens tablets, USP):

Tablet Strength Tablet Shape/Color Imprint
0.3 mg oval/green PREMARIN 0.3
0.45 mg oval/blue PREMARIN 0.45
0.625 mg oval/maroon PREMARIN 0.625
0.9 mg oval/white PREMARIN 0.9
1.25 mg oval/yellow PREMARIN 1.25
How Supplied

PREMARIN (conjugated estrogens tablets, USP)

  • Each oval green tablet contains 0.3 mg, in bottles of 100 (NDC 0046-1100-81) and 1,000 (NDC 0046-1100-91).
  • Each oval blue tablet contains 0.45 mg, in bottles of 100 (NDC 0046-1101-81).
  • Each oval maroon tablet contains 0.625 mg, in bottles of 100 (NDC 0046-1102-81) and 1,000 (NDC 0046-1102-91).
  • Each oval white tablet contains 0.9 mg, in bottles of 100 (NDC 0046-1103-81).
  • Each oval yellow tablet contains 1.25 mg, in bottles of 100 (NDC 0046-1104-81) and 1,000 (NDC 0046-1104-91).

The appearance of these tablets is a trademark of Wyeth LLC.

Drugs

Drug Countries
PREMARIN Brazil, Canada, Hong Kong, Ireland, Japan, Malta, Mexico, New Zealand, Singapore, United Kingdom, United States
 
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