50458-197 : Ortho-cyclen 28 Day Pack


NDC50458-197
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Ortho Cyclen
Dosage Form: Kit
Application #: NDA019653
Rev. Date: 


Appearance:


Markings: O;250;35
O;M;P
Shapes:  Round
Colors:  Green
Blue
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:

  • 50458-197-06: 6 BLISTER PACK IN 1 CARTON (50458‑197‑06) > 1 KIT IN 1 BLISTER PACK (50458‑197‑28)
  • 50458-197-12: 12 DIALPACK IN 1 CARTON (50458‑197‑12) > 1 KIT IN 1 DIALPACK
  • 50458-197-15: 6 BLISTER PACK IN 1 CARTON (50458‑197‑15) > 1 KIT IN 1 BLISTER PACK
  • 50458-197-20: 1 KIT IN 1 BLISTER PACK (50458‑197‑20)

Active Ingredients:

  • Norgestimate and Ethinyl Estradiol

Kit Contents:

  • Inert
  • Ortho Cyclen

Inactive Ingredients:

  • Fd&c Blue No. 2
  • Aluminum Oxide
  • Carnauba Wax
  • Croscarmellose Sodium
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Polysorbate 80
  • Titanium Dioxide
  • Water
  • Fd&c Blue No. 2
  • Aluminum Oxide
  • Ferric Oxide Red
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Polyethylene Glycols
  • Starch, Corn
  • Talc
  • Titanium Dioxide
  • Water

NDC QR Code

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NDC 50458-197 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.