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NDC Code(s): 69512-627-10 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 16, 2015
If you are a consumer or patient please visit this version.
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- DESCRIPTION
Each capsule contains:
Tramadol Hydrochloride, USP ..........50 mg
- DESCRIPTION
Usual Dosage: For dosage and other prescribing
information, see accompanying insert.
- STORAGE AND HANDLING
Store at 20 to 25 C (68 to 77 F); excursions
permitted to 15 to 30 C (59 to 86 F)[See
USP Controlled Room Temperature]
Dispense in a tight container as defined in
See AlsoWhat Is Your Round White Pill? 21 PossibilitiesTramadol: Side Effects, Dosage, Uses, and MoreTRAMADOL HYDROCHLORIDE tablet, film coatedthe USP.
Keep out of reach of children.
- DESCRIPTION
DESCRIPTION
Tramadol hydrochloride tablets, USP are a centrally acting analgesic.
- CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid
analgesic.
- CLINICAL STUDIES
CLINICAL STUDIES
Tramadol hydrochloride has been given in single oral doses pf 50, 75 and 100 mg to patients with pain
following surgical procedures and pain following oral surgery (extraction if impacted molars).
-
INDICATIONS AND USAGE
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to
moderately severe pain in adults.
- CONTRAINDICATIONS
CONTRAINDICATIONS
Tramadol hydrochloride tablets, USP should not be administered to patients who have previously
demonstrated hypersensitivity to tramadol, any other component of this product or opoids.
- WARNINGS
WARNINGS
Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the
recommended dosage range.
- PRECAUTIONS
PRECAUTIONS
Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment
of patients with acute abdominal conditions
- ADVERSE REACTIONS
ADVERSE REACTIONS
Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label
extension periods in U.S. clinical studies of chronic nonmalignant pain.
- DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE.
Abuse Tramadol has mu-opoid agonist activity.
- OVERDOSAGE
OVERDOSAGE
Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to
stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures,
bradycardia, hypotension, cardiac arrest, and death.
-
DOSAGE AND ADMINISTRATION
Adults (17 years of age and older) For patients with moderate to moderately severe chronic pain not
requiringrapid onset of analgesic effect, the tolerability of tramadol hydrochloride, USP can be improved by
initiating therapy with a titration regimen:
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-627 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 50mg in50mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (White) Score no score Shape ROUND Size 9mm Flavor Imprint Code AN;627 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69512-627-10 100 in 1 BOTTLE 1 50 mg in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076003 10/01/2015 Labeler -Alivio Medical Products, LLC(079670828)
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More Info on this Drug
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TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Oct 19, 2015 | 2 (current) | download |
RxNorm
TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 835603 | traMADol HCl 50 MG Oral Tablet | PSN |
| 2 | 835603 | tramadol hydrochloride 50 MG Oral Tablet | SCD |
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NDC Codes
TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 69512-627-10 (inactivated) |
