0591-0398 : Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet


NDC: 0591-0398
Labeler: Watson Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Diclofenac Sodium and Misoprostol
Dosage Form: Oral Tablet, Delayed Release
Application #: ANDA201089
Rev. Date: 


Appearance:


Markings: 398
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.

398: (0591-0398) Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Watson Laboratories, 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:

  • 0591-0398-19: 90 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (0591‑0398‑19)
  • 0591-0398-60: 60 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (0591‑0398‑60)

Active Ingredients:

  • Diclofenac Sodium
  • Misoprostol

Dosage Strength:

  • 75 mg
  • 200 ug/1

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hydrogenated Castor Oil
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone K30
  • Sodium Hydroxide
  • Starch, Corn
  • Talc
  • Triethyl Citrate
  • Polysorbate 80
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Sodium Lauryl Sulfate

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Prostaglandin E1 Analog [EPC]
  • Prostaglandins E
  • Synthetic [CS]

Related Products:

Based on records with the same trade name.
  • 0591-0397 Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Watson Laboratories, Inc.
  • 10544-949 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Blenheim Pharmacal, Inc.
  • 42291-232 Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Avkare, Inc.
  • 42291-233 Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Avkare, Inc.
  • 50090-4618 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by A-s Medication Solutions
  • 55648-215 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Wockhardt Limited
  • 55648-217 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Wockhardt Limited
  • 59762-0028 Diclofenac Sodium (Enteric Coated Core) 50 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Greenstone LLC
  • 59762-0029 Diclofenac Sodium (Enteric Coated Core) 75 mg / Misoprostol (Non-enteric Coated Mantle) 200 Mcg Oral Tablet by Greenstone LLC
  • 61919-094 Diclofenac Sodium and Misoprostol Oral Tablet, Film Coated by Direct Rx
  • 63629-4970 Diclofenac Sodium and Misoprostol (Diclofenac Sodium 75 mg / Misoprostol 200 Ug) by Bryant Ranch Prepack
  • 63629-7034 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Bryant Ranch Prepack
  • 64679-215 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Wockhardt USA LLC.
  • 64679-217 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Wockhardt USA LLC.
  • 65162-436 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Amneal Pharmaceuticals, LLC
  • 65162-438 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Amneal Pharmaceuticals, LLC
  • 68001-231 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Bluepoint Laboratories
  • 68001-232 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Bluepoint Laboratories
  • 68084-978 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by American Health Packaging
  • 68788-7103 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Preferred Pharmaceuticals Inc.
  • More related products ...

NDC QR Code

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NDC 0591-0398 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.