71335-0619 : Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated


NDC: 71335-0619
Labeler: Bryant Ranch Prepack
Product Type: Human Prescription Drug
Drug Name:  Tramadol Hydrochloride and Acetaminophen
Dosage Form: Oral Tablet, Film Coated
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:

  • 71335-0619-1: 30 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑1)
  • 71335-0619-2: 60 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑2)
  • 71335-0619-3: 90 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑3)
  • 71335-0619-4: 120 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑4)
  • 71335-0619-5: 20 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑5)
  • 71335-0619-6: 40 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑6)
  • 71335-0619-7: 100 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑7)
  • 71335-0619-8: 15 TABLET, FILM COATED IN 1 BOTTLE (71335‑0619‑8)

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.
  • 71335-0111 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Bryant Ranch Prepack
  • 71335-0151 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 71335-1742 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 63629-3406 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Bryant Ranch Prepack
  • 63629-4901 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Bryant Ranch Prepack
  • 0172-6359 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0378-8088 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 16590-230 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Stat Rx USA LLC
  • 21695-236 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Rebel Distributors Corp
  • 33261-389 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 33342-202 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Macleods Pharmaceuticals Limited
  • 33358-343 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Rxchange Co.
  • 35356-660 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-661 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 42254-051 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Rebel Distributors Corp
  • 42291-832 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Avkare, Inc.
  • 42549-569 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Stat Rx USA LLC
  • 42571-119 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Micro Labs Limited
  • 43063-599 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-782 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
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NDC QR Code

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NDC 71335-0619 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.