54569-5436 : Tramadol Hydrochloride 50 mg Oral Tablet

NDC:	54569-5436
Labeler:	A-s Medication Solutions LLC
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA075964
Rev. Date:	Jun 22, 2002
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:	377
Shapes:	Capsule
Colors:	White
Size (mm):	13
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:

54569-5436-0: 30 TABLET IN 1 BOTTLE (54569‑5436‑0)
54569-5436-1: 20 TABLET IN 1 BOTTLE (54569‑5436‑1)
54569-5436-2: 50 TABLET IN 1 BOTTLE (54569‑5436‑2)
54569-5436-3: 100 TABLET IN 1 BOTTLE (54569‑5436‑3)
54569-5436-4: 15 TABLET IN 1 BOTTLE (54569‑5436‑4)
54569-5436-5: 60 TABLET IN 1 BOTTLE (54569‑5436‑5)
54569-5436-7: 45 TABLET IN 1 BOTTLE (54569‑5436‑7)
54569-5436-9: 120 TABLET IN 1 BOTTLE (54569‑5436‑9)

Active Ingredients:

Tramadol Hydrochloride

Dosage Strength:

50 mg

Inactive Ingredients:

Starch, Corn
Anhydrous Lactose
Magnesium Stearate
Cellulose, Microcrystalline
Polyethylene Glycols
Sodium Starch Glycolate Type a Potato
Titanium Dioxide

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.