0406-8953 : Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release
| NDC: | 0406-8953 |
| Labeler: | Specgx LLC |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Mixed Salts of a Single Entity Amphetamine Product XR |
| Dosage Form: | Oral Capsule, Extended Release |
| Application #: | ANDA211547 |
| 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: | 15;mg;M;8953 |
| Shapes: |
Capsule |
| Colors: |
 Blue /
 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:
- 0406-8953-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0406‑8953‑01)
Active Ingredients:
- Dextroamphetamine Sulfate
- Dextroamphetamine Saccharate
- Amphetamine Aspartate Monohydrate
- Amphetamine Sulfate
Dosage Strength:
- 3.75 mg
- 3.75 mg
- 3.75 mg
- 3.75 mg
Inactive Ingredients:
- Gelatin, Unspecified
- Hydroxypropyl Cellulose, Unspecified
- Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
- Sucrose
- Talc
- Triethyl Citrate
- Fd&c Blue No. 1
- Titanium Dioxide
- D&c Red No. 28
- Starch, Corn
- Sodium Lauryl Sulfate
- Shellac
- Propylene Glycol
- Ferrosoferric Oxide
- Alcohol
- Ferrous Oxide
- Polysorbate 80 /
Pharmaceutical Classes:
- Central Nervous System Stimulant [EPC]
- Central Nervous System Stimulation [PE]
Related Products:
Based on records with the same trade name.- 0406-8951 Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release by Specgx LLC
- 0406-8952 Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release by Specgx LLC
- 0406-8954 Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release by Specgx LLC
- 0406-8955 Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release by Specgx LLC
- 0406-8956 Mixed Salts of a Single Entity Amphetamine Product Oral Capsule, Extended Release by Specgx LLC
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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.