63304-096 : Erlotinib 100 mg Oral Tablet, Film Coated


NDC: 63304-096
Labeler: Sun Pharmaceutical Industries, Inc.
Product Type: Human Prescription Drug
Drug Name:  Erlotinib
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA210300
Rev. Date: 


Appearance:


Markings: RL12
Shapes:  Round
Colors:  White
Size (mm): 10
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:

  • 63304-096-11: 3 BLISTER PACK IN 1 CARTON (63304‑096‑11) > 10 TABLET, FILM COATED IN 1 BLISTER PACK (63304‑096‑31)
  • 63304-096-30: 30 TABLET, FILM COATED IN 1 BOTTLE (63304‑096‑30)

Active Ingredients:

  • Erlotinib

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Hypromellose 2208 (100 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol, Unspecified
  • Sodium Lauryl Sulfate
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide /

Pharmaceutical Classes:

  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
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  • 63304-135 Erlotinib 150 mg Oral Tablet, Film Coated by Sun Pharmaceutical Industries, Inc.
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  • 51991-892 Erlotinib 150 mg Oral Tablet, Film Coated by Breckenridge Pharmaceutical, Inc.
  • 59651-530 Erlotinib 25 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
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  • 59651-532 Erlotinib 150 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
  • 59923-725 Erlotinib 25 mg Oral Tablet, Film Coated by Areva Pharmaceuticals
  • 59923-726 Erlotinib 100 mg Oral Tablet, Film Coated by Areva Pharmaceuticals
  • 59923-727 Erlotinib 150 mg Oral Tablet, Film Coated by Areva Pharmaceuticals
  • 68382-913 Erlotinib 25 mg Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.
  • 68382-914 Erlotinib 100 mg Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.
  • 68382-915 Erlotinib 150 mg Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.
  • 70771-1521 Erlotinib 25 mg Oral Tablet, Film Coated by Cadila Healthcare Limited
  • 70771-1522 Erlotinib 100 mg Oral Tablet, Film Coated by Cadila Healthcare Limited
  • 70771-1523 Erlotinib 150 mg Oral Tablet, Film Coated by Cadila Healthcare Limited
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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.