63629-8319 : Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release

NDC:	63629-8319
Labeler:	Bryant Ranch Prepack
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA200503
Rev. Date:	Aug 19, 2014
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:	L011
Shapes:	Round
Colors:	White
Size (mm):	9
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:

63629-8319-1: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63629‑8319‑1)
63629-8319-2: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63629‑8319‑2)
63629-8319-3: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63629‑8319‑3)
63629-8319-4: 120 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63629‑8319‑4)

Active Ingredients:

Tramadol Hydrochloride

Dosage Strength:

200 mg

Inactive Ingredients:

Microcrystalline Cellulose
Dibutyl Sebacate
Ethylcellulose, Unspecified
Ferrosoferric Oxide
Povidone, Unspecified
Propylene Glycol
Shellac
Silicon Dioxide
Sodium Stearyl Fumarate /

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 63629-8319 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.