0603-3897 : Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet
| NDC: | 0603-3897 |
| Labeler: | Qualitest Pharmaceuticals |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Hydrocodone Bitartrate and Ibuprofen |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | ANDA077723 |
| 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: | 3585;V |
| Shapes: |
Round |
| Colors: |
 White |
| Size (mm): | 11 |
| 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. | |
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.
NDC Package Codes:
- 0603-3897-10: 10 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0603‑3897‑10)
- 0603-3897-21: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0603‑3897‑21)
- 0603-3897-28: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0603‑3897‑28)
- 0603-3897-32: 1000 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0603‑3897‑32)
Active Ingredients:
- Hydrocodone Bitartrate
- Ibuprofen
Dosage Strength:
- 7.5 mg
- 200 mg
Inactive Ingredients:
- Silicon Dioxide
- Hypromellose
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polyethylene Glycol
- Polysorbate 80
- Povidone
- Starch, Corn
- Sodium Starch Glycolate Type a Potato
- Titanium Dioxide
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.- 0603-3584 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Qualitest Pharmaceuticals
- 0603-3586 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Qualitest Pharmaceuticals
- 0093-5161 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Teva Pharmaceuticals USA Inc
- 13107-004 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Aurolife Pharma, LLC
- 16590-296 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Stat Rx USA LLC
- 33261-378 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Aidarex Pharmaceuticals LLC
- 35356-586 Hydrocodone Bitartrate 5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC Care Producst
- 35356-804 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC Care Producst
- 42549-656 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Stat Rx USA LLC
- 43063-349 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
- 49999-588 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
- 52959-738 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by H.j. Harkins Company, Inc.
- 53746-116 Hydrocodone Bitartrate 2.5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
- 53746-117 Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
- 53746-145 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
- 53746-146 Hydrocodone Bitartrate 5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
- 54569-6121 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by A-s Medication Solutions LLC
- 54868-4976 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Physicians Total Care, Inc.
- 55289-944 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
- 55700-639 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Lake Erie Medical Dba Quality Care Products LLC
- More related products ...
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.