54868-4703 : Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet

NDC:	54868-4703
Labeler:	Physicians Total Care, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Ultracet
Dosage Form:	Oral Tablet, Coated
Application #:	NDA021123
Rev. Date:	Oct 30, 2002

Appearance:

Markings:	O;M;650
Shapes:	Oval
Colors:	Yellow
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.

O M 650: (50458-650) Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Physicians Total Care, Inc.

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:

54868-4703-1: 10 TABLET, COATED IN 1 BOTTLE (54868‑4703‑1)
54868-4703-4: 60 TABLET, COATED IN 1 BOTTLE (54868‑4703‑4)

Active Ingredients:

Acetaminophen
Tramadol Hydrochloride

Dosage Strength:

325 mg
37.5 mg

Inactive Ingredients:

Powdered Cellulose
Sodium Starch Glycolate Type a Potato
Starch, Corn
Magnesium Stearate
Hypromelloses
Polyethylene Glycols
Polysorbate 80
Titanium Dioxide
Ferrosoferric Oxide
Carnauba Wax

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC 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.