54868-5957 : Tussicaps (Chlorpheniramine 8 mg / Hydrocodone Bitartrate 10 mg) 12 Hr Extended Release Capsule
NDC: | 54868-5957 |
Labeler: | Physicians Total Care, Inc. |
Product Type: | Human Prescription Drug |
Drug Name: | Tussicaps |
Dosage Form: | Oral Capsule, Extended Release |
Application #: | ANDA077273 |
Rev. Date: | |
CSA Schedule: | CIII (US) [1] |
[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
Markings: | M;HP;CP;10;8 |
Shapes: |
Capsule |
Colors: |
White /
White |
Size (mm): | 20 |
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:
- 54868-5957-0: 20 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (54868‑5957‑0)
Active Ingredients:
- Chlorpheniramine Maleate
- Hydrocodone Bitartrate
Dosage Strength:
- 8 mg
- 10 mg
Inactive Ingredients:
- Butyl Alcohol
- Gelatin
- Ferrosoferric Oxide
- Isopropyl Alcohol
- Cellulose, Microcrystalline
- Propylene Glycol
- Water
- Shellac
- Ammonia
- Titanium Dioxide
- D&c Yellow No. 10
- Aluminum Oxide
- Fd&c Blue No. 1
- Fd&c Blue No. 2
- Indigotindisulfonate Sodium
- Fd&c Red No. 40
- Alcohol
- Methyl Alcohol
Pharmaceutical Classes:
- Opioid Agonist [EPC]
- Opioid Agonists [MoA]
- Histamine H1 Receptor Antagonists [MoA]
- Histamine-1 Receptor Antagonist [EPC]
Related Products:
Based on records with the same trade name.- 0095-0054 Tussicaps Half-strength (Chlorpheniramine 4 mg / Hydrocodone Bitartrate 5 mg) 12 Hr Extended Release Capsule by Ecr Pharmaceuticals
- 0095-0108 Tussicaps (Chlorpheniramine 8 mg / Hydrocodone Bitartrate 10 mg) 12 Hr Extended Release Capsule by Ecr Pharmaceuticals
- 0187-0054 Tussicaps Oral Capsule, Extended Release by Valeant Pharmaceuticals North America LLC
- 0187-0108 Tussicaps Oral Capsule, Extended Release by Valeant Pharmaceuticals North America LLC
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.