55700-557 : Xtampza 13.5 mg Oral Capsule, Extended Release
| NDC: | 55700-557 |
| Labeler: | Lake Erie Medical Dba Quality Care Products LLC |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Xtampza ER |
| Dosage Form: | Oral Capsule, Extended Release |
| Application #: | NDA208090 |
| Rev. Date: | |
| CSA Schedule: | CII (US) [1] |
[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
| Markings: | XTAMPZA;ER;13;5;mg |
| Shapes: |
Capsule |
| Colors: |
 Orange /
 White |
| Size (mm): | 18 |
| 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:
- 55700-557-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (55700‑557‑30)
Active Ingredients:
- Oxycodone
Dosage Strength:
- 13.5 mg
Inactive Ingredients:
- Myristic Acid
- Yellow Wax
- Carnauba Wax
- Peg-32 Stearate
- Magnesium Stearate
- Silicon Dioxide
- Hypromellose, Unspecified
- Titanium Dioxide
- Water
- Ferric Oxide Red
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
Based on records with the same trade name.- 24510-110 Xtampza 9 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
- 24510-115 Xtampza 13.5 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
- 24510-120 Xtampza 18 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
- 24510-130 Xtampza 27 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
- 24510-140 Xtampza 36 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
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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.