33342-362 : Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Oral Tablet


NDC33342-362
Labeler: Macleods Pharmaceuticals Limited
Product Type: Human Prescription Drug
Drug Name:  Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Dosage Form: Oral Tablet
Application #: NDA210649
Rev. Date: 


Appearance:


Markings: F31
Shapes:  Capsule
Colors:  Pink
Size (mm): 21
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:

  • 33342-362-07: 30 TABLET IN 1 BOTTLE (33342‑362‑07)
  • 33342-362-10: 90 TABLET IN 1 BOTTLE (33342‑362‑10)
  • 33342-362-57: 180 TABLET IN 1 BOTTLE (33342‑362‑57)

Active Ingredients:

  • Efavirenz
  • Lamivudine
  • Tenofovir Disoproxil Fumarate

Dosage Strength:

  • 400 mg
  • 300 mg
  • 300 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Croscarmellose Sodium
  • Poloxamer 188
  • Hydroxypropyl Cellulose, Unspecified
  • Sodium Lauryl Sulfate
  • Starch, Corn
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Hypromelloses
  • Titanium Dioxide
  • Ferric Oxide Red
  • Triacetin /

Pharmaceutical Classes:

  • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Non-Nucleoside Analog [EXT]
  • Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Cytochrome P450 2B6 Inducers [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleoside Analog [EXT]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 42385-928 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Oral Tablet, Film Coated by Laurus Labs Limited
  • 42385-929 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Oral Tablet, Film Coated by Laurus Labs Limited

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 33342-362 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.