35356-767 : Tramadol Hydrochloride 150 mg 24 Hr Extended Release Capsule

NDC:	35356-767
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA022370
Rev. Date:	Mar 14, 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:	G;322;150
Shapes:	Capsule
Colors:	White
Size (mm):	19
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:

35356-767-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (35356‑767‑30)
35356-767-60: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (35356‑767‑60)
35356-767-90: 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (35356‑767‑90)

Active Ingredients:

Tramadol Hydrochloride

Dosage Strength:

150 mg

Inactive Ingredients:

Gelatin
Titanium Dioxide
Shellac
Ferric Oxide Yellow
Lactose Monohydrate
Cellulose, Microcrystalline
Sucrose Stearate
Povidone K30
Starch, Corn
Magnesium Stearate
Hypromellose 2910 (6 Mpa.s)
Talc
Polysorbate 80
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 Mw)

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.