42571-119 : Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet

NDC:	42571-119
Labeler:	Micro Labs Limited
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride and Acetaminophen
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA201952
Rev. Date:	Dec 15, 2012
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:	I03
Shapes:	Oval
Colors:	Yellow
Size (mm):	16
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:

• 42571-119-01: 100 TABLET, FILM COATED IN 1 BOTTLE (42571‑119‑01)
• 42571-119-05: 500 TABLET, FILM COATED IN 1 BOTTLE (42571‑119‑05)
• 42571-119-10: 1000 TABLET, FILM COATED IN 1 BOTTLE (42571‑119‑10)
• 42571-119-23: 8 BLISTER PACK IN 1 CARTON (42571‑119‑23) > 10 TABLET, FILM COATED IN 1 BLISTER PACK (42571‑119‑32)
• 42571-119-90: 90 TABLET, FILM COATED IN 1 BOTTLE (42571‑119‑90)

Active Ingredients:

• Tramadol Hydrochloride
• Acetaminophen

Inactive Ingredients:

• Starch, Corn
• Powdered Cellulose
• Sodium Starch Glycolate Type a Potato
• Magnesium Stearate
• Titanium Dioxide
• Polyethylene Glycol 400
• Ferric Oxide Yellow
• Polysorbate 80
• Hypromellose 2910 (3 Mpa.s)
• Hypromellose 2910 (6 Mpa.s)

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 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
• 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.
• 43063-837 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
• 45865-170 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Medsource Pharmaceuticals
• 45865-469 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Medsource Pharmaceuticals
• 47781-219 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Alvogen, Inc.
• 49349-853 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Remedyrepack Inc.
• 49884-946 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Par Pharmaceutical Inc.
• More related products ...

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