68180-827 : Fyavolv Oral Tablet, Film Coated

Labeler: Lupin Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fyavolv
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA204213
Rev. Date: 


Markings: LU;F51
Shapes:  Round
Colors:  White
Size (mm): 6
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 68180-827-09: 1 BOTTLE IN 1 CARTON (68180‑827‑09) > 90 TABLET, FILM COATED IN 1 BOTTLE
  • 68180-827-13: 3 POUCH IN 1 CARTON (68180‑827‑13) > 1 BLISTER PACK IN 1 POUCH (68180‑827‑11) > 28 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Ethinyl Estradiol
  • Norethindrone Acetate

Dosage Strength:

  • .0025 mg
  • .5 mg

Inactive Ingredients:

  • Calcium Stearate
  • Cellulose, Microcrystalline
  • Hypromelloses
  • Lactose Monohydrate
  • Polyethylene Glycol 400
  • Starch, Corn
  • Titanium Dioxide
  • Tocopherol

Pharmaceutical Classes:

  • Estrogen Receptor Agonists [MoA]
  • Estrogen [EPC]
  • Progesterone Congeners [CS]
  • Progestin [EPC]

Related Products:

Based on records with the same trade name.
  • 68180-828 Fyavolv Oral Tablet, Film Coated by Lupin Pharmaceuticals, Inc.


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NDC 68180-827 QR Code

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