13668-476 : Roflumilast 500 ug/1 Oral Tablet


NDC: 13668-476
Labeler: Torrent Pharmaceuticals Limited
Product Type: Human Prescription Drug
Drug Name:  Roflumilast
Dosage Form: Oral Tablet
Application #: ANDA208272
Rev. Date: 


Appearance:


Markings: 76
Shapes:  Round
Colors:  White
Size (mm): 5
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:

  • 13668-476-05: 500 TABLET IN 1 BOTTLE (13668‑476‑05)
  • 13668-476-30: 30 TABLET IN 1 BOTTLE (13668‑476‑30)
  • 13668-476-74: 100 TABLET IN 1 CARTON (13668‑476‑74)
  • 13668-476-90: 90 TABLET IN 1 BOTTLE (13668‑476‑90)

Active Ingredients:

  • Roflumilast

Dosage Strength:

  • 500 ug/1

Inactive Ingredients:

  • Carboxymethylcellulose Calcium
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyvinyl Alcohol, Unspecified
  • Starch, Corn /

Pharmaceutical Classes:

  • Phosphodiesterase 4 Inhibitor [EPC]
  • Phosphodiesterase 4 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-1905 Roflumilast 500 ug/1 Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0904-7399 Roflumilast 500 ug/1 Oral Tablet by Major Pharmaceuticals
  • 31722-623 Roflumilast 500 ug/1 Oral Tablet by Camber Pharmaceuticals, Inc.
  • 31722-676 Roflumilast 250 ug/1 Oral Tablet by Camber Pharmaceuticals, Inc.
  • 42571-259 Roflumilast 500 ug/1 Oral Tablet by Micro Labs Limited
  • 42571-369 Roflumilast 250 ug/1 Oral Tablet by Micro Labs Limited
  • 43547-005 Roflumilast 500 ug/1 Oral Tablet by Solco Healthcare Us, LLC.
  • 59651-275 Roflumilast 500 ug/1 Oral Tablet by Aurobindo Pharma Limited
  • 60687-786 Roflumilast 500 ug/1 Oral Tablet by American Health Packaging
  • 64380-786 Roflumilast 500 ug/1 Oral Tablet by Strides Pharma Science Limited
  • 68382-624 Roflumilast 250 ug/1 Oral Tablet by Zydus Pharmaceuticals USA Inc.
  • 68382-969 Roflumilast 500 ug/1 Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.
  • 70771-1673 Roflumilast 250 ug/1 Oral Tablet by Zydus Lifesciences Limited
  • 70771-1674 Roflumilast 500 ug/1 Oral Tablet by Cadila Healthcare Limited
  • 72205-200 Roflumilast 500 ug/1 Oral Tablet by Novadoz Pharmaceuticals LLC
  • 72205-201 Roflumilast 250 ug/1 Oral Tablet by Novadoz Pharmaceuticals LLC

NDC QR Code

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NDC 13668-476 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.