50458-251 : Ortho Tri-cyclen Lo 28 Day Pack


NDC: 50458-251
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Ortho Tri Cyclen Lo
Dosage Form: Kit
Application #: NDA021241
Rev. Date: 


Appearance:


Markings: O;M;180
O;M;215
O;M;250
O;M;P
Shapes:  Round
Colors:  White
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:

  • 50458-251-06: 6 BLISTER PACK IN 1 CARTON (50458‑251‑06) > 1 KIT IN 1 BLISTER PACK (50458‑251‑28)
  • 50458-251-12: 12 DIALPACK IN 1 CARTON (50458‑251‑12) > 1 KIT IN 1 DIALPACK (50458‑251‑00)
  • 50458-251-15: 6 DIALPACK IN 1 CARTON (50458‑251‑15) > 1 KIT IN 1 DIALPACK (50458‑251‑00)
  • 50458-251-20: 48 DIALPACK IN 1 CARTON (50458‑251‑20) > 1 KIT IN 1 DIALPACK (50458‑251‑00)

Active Ingredients:

  • Norgestimate and Ethinyl Estradiol

Kit Contents:

  • Inert
  • Norgestimate and Ethinyl Estradiol

Inactive Ingredients:

  • Carnauba Wax
  • Croscarmellose Sodium
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Titanium Dioxide
  • Water
  • 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
  • Carnauba Wax
  • Croscarmellose Sodium
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • 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

Related Products:

Based on records with the same trade name.
  • 54868-4730 Ortho Tri-cyclen Lo 28 Day Pack by Physicians Total Care, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 50458-251 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.