50991-578 : Ibudone (Hydrocodone Bitartrate 5 mg / Ibuprofen 200 mg) Oral Tablet
| NDC: | 50991-578 |
| Labeler: | Poly Pharmaceuticals |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Ibudone |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | ANDA077727 |
| 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: | 3584;V |
| Shapes: |
Oval |
| Colors: |
 White |
| Size (mm): | 14 |
| Segments: * | 2 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces. | |
NDC Package Codes:
- 50991-578-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (50991‑578‑01)
- 50991-578-40: 20 POUCH IN 1 CARTON (50991‑578‑40) > 1 TABLET, FILM COATED IN 1 POUCH
Active Ingredients:
- Hydrocodone Bitartrate
- Ibuprofen
Dosage Strength:
- 5 mg
- 200 mg
Inactive Ingredients:
- Silicon Dioxide
- Hypromellose
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polyethylene Glycol
- Povidone
- Starch, Corn
- Sodium Starch Glycolate Type a Potato
- Titanium Dioxide
- Polysorbate 80
Pharmaceutical Classes:
- Opioid Agonist [EPC]
- Opioid Agonists [MoA]
- Cyclooxygenase Inhibitors [MoA]
- Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
- Nonsteroidal Anti-inflammatory Drug [EPC]
Related Products:
Based on records with the same trade name.- 50991-579 Ibudone (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Poly Pharmaceuticals
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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.