43353-095 : Ibuprofen 800 mg Oral Tablet, Film Coated


NDC: 43353-095
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name:  Ibuprofen
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA075682
Rev. Date: 


Appearance:


Markings: 8I
Shapes:  Capsule
Colors:  White
Size (mm): 19
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:

  • 43353-095-60: 90 TABLET, FILM COATED IN 1 BOTTLE (43353‑095‑60)
  • 43353-095-80: 180 TABLET, FILM COATED IN 1 BOTTLE (43353‑095‑80)
  • 43353-095-92: 270 TABLET, FILM COATED IN 1 BOTTLE (43353‑095‑92)

Active Ingredients:

  • Ibuprofen

Dosage Strength:

  • 800 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Copovidone K25-31
  • Sodium Starch Glycolate Type a Potato
  • Silicon Dioxide
  • Magnesium Stearate
  • Polysorbate 80

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.
  • 43353-314 Ibuprofen 600 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-389 Ibuprofen 400 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-391 Ibuprofen 800 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-393 Ibuprofen 600 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 71610-154 Ibuprofen 800 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-176 Ibuprofen 600 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-202 Ibuprofen 800 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-222 Ibuprofen 600 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-296 Ibuprofen 400 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-387 Ibuprofen 800 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-414 Ibuprofen 400 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-456 Ibuprofen by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-505 Ibuprofen 800 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-532 Ibuprofen 600 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-627 Ibuprofen 400 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-629 Ibuprofen 600 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-644 Ibuprofen 400 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-645 Ibuprofen 600 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-646 Ibuprofen 800 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 0121-0918 Ibuprofen 100 mg/5ml Oral Suspension by Pharmaceutical Associates, Inc.
  • More related products ...

NDC QR Code

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NDC 43353-095 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.