ULTRACET
- Product NDC
- 21695-143
- 11-digit product format
- 216950143
- Labeler code
- 21695
- Product ID
- 21695-143_750e7372-022b-454e-86c4-e4b325fb9f42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021123
- Marketing category
- NDA
- Marketing start
- 2001-08-15
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 43d017e1-6ae6-7555-71d1-c249236d6f26 | Product name | 4 | 20251117 |
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| c563c906-2606-457c-bb1b-5a623daed55b | Product name | 1 | 20210511 |
| 43a9f8f9-34aa-8ae8-719e-5489454f7720 | Product name | 5 | 20200123 |
| abd2f6f2-3fa7-4571-af8a-d67f89bdcb75 | Product name | 1 | 20190927 |
| 377068df-225f-7318-a910-a1987cdfa361 | Product name | 3 | 20170608 |
| 9457302e-0ca3-d9ff-0863-1b24b6107218 | Product name | 1 | 20140508 |
| d5c49867-1fe9-7a44-3319-814417011d51 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-143-72 | 2019-09-24 | C162847 | 48780-1 | 934fe258-491d-48b1-e053-8cdaa90a720a | ULTRACET ® (TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN) TABLETS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-143-72 | ULTRACET | 120 in 1 BOTTLE | TABLET | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-143-72 | EA - Each | 21695-143 | 0474fb86-b4eb-41d2-a15e-840c22834de4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 836395 | traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836397 | ULTRACET 37.5 MG / 325 MG Oral Tablet | PSN | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836397 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet [Ultracet] | SBD | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836395 | acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SCD | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836395 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet | SY | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836397 | APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet [Ultracet] | SY | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
| 836397 | Ultracet (APAP 325 MG / tramadol hydrochloride 37.5 MG) Oral Tablet | SY | 750e7372-022b-454e-86c4-e4b325fb9f42 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-143-72 | 21695014372 | 120 in 1 BOTTLE | Historical |