Prescription drug · ANDA
Trezix NDC 63187-705
acetaminophen, caffeine, dihydrocodeine bitartrate · Acetaminophen 320.5 mg/1 + 2 more ingredients · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-705-00 | 63187070500 | 100 CAPSULE in 1 BOTTLE (63187-705-00)Marketed from Jun 1, 2016 | |
| 63187-705-30 | 63187070530 | 30 CAPSULE in 1 BOTTLE (63187-705-30)Marketed from Jun 1, 2016 | |
| 63187-705-60 | 63187070560 | 60 CAPSULE in 1 BOTTLE (63187-705-60)Marketed from Jun 1, 2016 | |
| 63187-705-72 | 63187070572 | 120 CAPSULE in 1 BOTTLE (63187-705-72)Marketed from Aug 1, 2018 | |
| 63187-705-90 | 63187070590 | 90 CAPSULE in 1 BOTTLE (63187-705-90)Marketed from Jun 1, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Trezix
- Generic name (nonproprietary)
- acetaminophen, caffeine, dihydrocodeine bitartrate
- Active ingredients
- Acetaminophen — 320.5 mg/1Caffeine — 30 mg/1Dihydrocodeine bitartrate — 16 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204785
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
- Identifiers
- Product ID 63187-705_cf14c5ce-0aa3-4511-9db0-7d5aa995f04dSPL ID cf14c5ce-0aa3-4511-9db0-7d5aa995f04dSPL set ID 45c3c2a1-6a89-471e-b6d4-5a4cd73b987aRxCUI 1190201, 1596108UNII 362O9ITL9D, 3G6A5W338E, 8LXS95BSA9UPC 0363187705602
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine; Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463187070500followed by a unit qualifier and the quantityPackage 63187-0705-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.
Excerpt only. Read the full label for complete information.
About NDC 63187-705
- What is NDC 63187-705?
- 63187-705 is the product NDC for Trezix, Acetaminophen 320.5 mg/1 + 2 more ingredients capsule, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trezix (Acetaminophen, caffeine, dihydrocodeine bitartrate).
- What is the active ingredient?
- Acetaminophen, Caffeine, Dihydrocodeine bitartrate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trezix?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.