DROSPIRENONE AND ETHINYL ESTRADIOL Kit / Tablets Ref.[10470] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

Drospirenone and ethinyl estradiol tablets contain 24 round pink tablets, and 4 round white tablets in a blister card (NDC 75834-116-84). Each pink tablet (debossed with “Z3” on one side) contains 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE). Each white tablet (debossed with “P” on one side and "N" on the other side) contains inert ingredients.

The inactive ingredients in the pink tablets are titanium dioxide, macrogol/PEG 3350 NF, talc, lecithin (soya), polyvinyl alcohol, iron oxide yellow, FD&C Yellow #6, FD&C Blue #2, FD&C Red#40, polysorbate 80, lactose monohydrate, magnesium stearate and pregelatinized starch.

The inert film coated tablets contain titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Drospirenone(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Ethinyl estradiol (19-nor-17 alpha -pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.

The structural formulas are as follows:

USP Dissolution Test is Pending.

Dosage Forms and Strengths

Drospirenone and ethinyl estradiol tablets provides an oral contraceptive regimen consisting of 28 round unscored tablets in a blister card (NDC 75834-116-84) that contain the ingredients specified for each tablet below:

  • 24 pink tablets each containing 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE) debossed with “Z3” on one side
  • 4 inert white tablets debossed with “P” on one side and "N" on the other side.
How Supplied

Drospirenone and ethinyl estradiol tablets contain 28 tablets in a blister card (NDC 75834-116-84). Each blister card contains, in the following order, 24 pink tablets and 4 white tablets. Each round, biconvex, pink tablet (debossed with “Z3” on one side) contains 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE). Each round, biconvex, white tablet (debossed with “P” on one side and "N" on the other side) contains inert ingredients.

Drospirenone and ethinyl estradiol tablets are available in the following packaging configuration:

Carton of 3 blister cards NDC 75834-116-29

Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827

Toll Free 1-877-977-0687

Manufactured by: Novast Laboratories Ltd., Nantong, China 226009

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.