Trezix
- Product NDC
- 63629-5637
- 11-digit product format
- 636295637
- Labeler code
- 63629
- Product ID
- 63629-5637_f90f87cb-77ad-45f4-8b59-09459090d988
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen, caffeine, dihydrocodeine bitartrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204785
- Marketing category
- ANDA
- Marketing start
- 2014-12-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
- Active strength
- 321 mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-5637-1 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-2 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-3 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-4 | 2020-10-16 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
| 63629-5637-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e2ea-f424-e053-dadaa90a57ce | f90f87cb-77ad-45f4-8b59-09459090d988 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-5637-1 | EA - Each | 63629-5637 | 2e8991df-d990-4808-acdb-6376e94a137c | 1 | 2017-03-06 |
| 63629-5637-2 | EA - Each | 63629-5637 | 16e143b5-6fa3-48cd-8432-c73c2abb262e | 1 | 2017-03-06 |
| 63629-5637-3 | EA - Each | 63629-5637 | 60e55cb6-a33a-4b9d-ab14-b6a4b3ea7e33 | 1 | 2017-03-06 |
| 63629-5637-4 | EA - Each | 63629-5637 | 48da6532-6f8f-4ab6-96b8-eb975b5f239f | 1 | 2017-03-06 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-5637-1 | 63629563701 | 30 CAPSULE in 1 BOTTLE (63629-5637-1) | 30 capsule | 2015-06-04 | 0000-00-00 | No | No | Current |
| 63629-5637-2 | 63629563702 | 60 CAPSULE in 1 BOTTLE (63629-5637-2) | 60 capsule | 2015-06-04 | 0000-00-00 | No | No | Current |
| 63629-5637-3 | 63629563703 | 90 CAPSULE in 1 BOTTLE (63629-5637-3) | 90 capsule | 2015-07-13 | 0000-00-00 | No | No | Current |
| 63629-5637-4 | 63629563704 | 120 CAPSULE in 1 BOTTLE (63629-5637-4) | 120 capsule | 2015-10-26 | 0000-00-00 | No | No | Current |