60846-902 : Reprexain Oral Tablet, Film Coated


NDC60846-902
Labeler: Gemini Laboratories, LLC
Product Type: Human Prescription Drug
Drug Name:  Reprexain
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA076642
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: IP;117
Shapes:  Round
Colors:  Yellow
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.

IP 117: (63717-902) Reprexain Oral Tablet, Film Coated by Gemini Laboratories, LLC
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:

  • 60846-902-01: 100 TABLET, FILM COATED IN 1 BOTTLE (60846‑902‑01)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Ibuprofen

Dosage Strength:

  • 10 mg
  • 200 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Polydextrose
  • Starch, Corn
  • Titanium Dioxide
  • Triacetin
  • D&c Yellow No. 10

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 60846-900 Reprexain Oral Tablet, Film Coated by Gemini Laboratories, LLC
  • 60846-901 Reprexain Oral Tablet, Film Coated by Gemini Laboratories, LLC
  • 16590-276 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Stat Rx USA
  • 16590-878 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Stat Rx USA
  • 23710-900 Reprexain 2.5/200 Oral Tablet by Quinnova Pharmaceuticals, LLC
  • 23710-901 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Quinnova Pharmaceuticals, LLC
  • 23710-902 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Quinnova Pharmaceuticals, LLC
  • 63717-900 Reprexain 2.5/200 Oral Tablet by Hawthorn Pharmaceuticals, Inc.
  • 63717-901 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Hawthorn Pharmaceuticals, Inc.
  • 63717-902 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Hawthorn Pharmaceuticals, Inc.

NDC QR Code

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NDC 60846-902 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.