61919-335 : Direct Rx Oral Tablet


NDC61919-335
Labeler: Direct Rx
Product Type: Human Prescription Drug
Drug Name:  Direct Rx
Dosage Form: Oral Tablet
Application #: ANDA090460
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 334
Shapes:  Capsule
Colors:  White
Size (mm): 15
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:

  • 61919-335-30: 30 TABLET IN 1 BOTTLE (61919‑335‑30)
  • 61919-335-60: 60 TABLET IN 1 BOTTLE (61919‑335‑60)
  • 61919-335-72: 72 TABLET IN 1 BOTTLE (61919‑335‑72)

Active Ingredients:

  • Acetaminophen
  • Tramadol Hydrochloride

Dosage Strength:

  • 325 mg
  • 37.5 mg

Inactive Ingredients:

  • Starch, Corn
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 6000
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 61919-061 Direct Rx Oral Tablet by Direct Rx
  • 61919-066 Direct Rx 500 mg Oral Tablet by Direct Rx
  • 61919-080 Direct Rx Oral Tablet by Direct Rx
  • 61919-208 Direct Rx Oral Tablet by Direct Rx
  • 61919-269 Direct Rx 1.5 mg Oral Tablet by Direct Rx
  • 61919-283 Direct Rx 200 mg Oral Tablet by Direct Rx
  • 61919-297 Direct Rx .125 mg Oral Tablet by Direct Rx
  • 61919-389 Direct Rx 20 mg Oral Tablet by Direct Rx
  • 61919-390 Direct Rx 40 mg Oral Tablet by Direct Rx
  • 61919-474 Direct Rx 100 mg Oral Tablet by Direct Rx
  • 61919-775 Direct Rx 100 mg Oral Capsule by Direct Rx
  • 61919-919 Direct Rx 1 g/1 Oral Capsule by Direct Rx

NDC QR Code

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