54868-4164 : Arthrotec (Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet


NDC: 54868-4164
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Arthrotec
Dosage Form: Oral Tablet, Film Coated
Application #: NDA020607
Rev. Date: 


Appearance:


Markings: SEARLE;1411;AAAA;50
Shapes:  Round
Colors:  White
Size (mm): 11
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.

SEARLE 1411 AAAA 50: (0025-1411) Arthrotec (Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Physicians Total Care, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54868-4164-0: 60 TABLET, FILM COATED IN 1 BOTTLE (54868‑4164‑0)
  • 54868-4164-1: 30 TABLET, FILM COATED IN 1 BOTTLE (54868‑4164‑1)

Active Ingredients:

  • Diclofenac Sodium
  • Misoprostol

Dosage Strength:

  • 50 mg
  • 200 ug/1

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hydrogenated Castor Oil
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone K30
  • Sodium Hydroxide
  • Starch, Corn
  • Talc
  • Triethyl Citrate

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Prostaglandin E1 Analog [EPC]
  • Prostaglandins E
  • Synthetic [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 54868-4165 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Physicians Total Care, Inc.
  • 0025-1411 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by G.d. Searle LLC Division of Pfizer Inc
  • 0025-1421 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by G.d. Searle LLC Division of Pfizer Inc
  • 16590-024 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Stat Rx USA LLC
  • 21695-425 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Rebel Distributors Corp.
  • 49999-987 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 54569-4579 Arthrotec Oral Tablet, Film Coated by A-s Medication Solutions
  • 55289-406 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 63629-3359 Arthrotec (Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg) Oral Tablet by Bryant Ranch Prepack

NDC QR Code

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NDC 54868-4164 QR Code

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