ULTRACET
- Product NDC
- 50458-650
- 11-digit product format
- 504580650
- Labeler code
- 50458
- Product ID
- 50458-650_a2b86fcc-0371-11ed-8fc7-fdbb42d6beab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride and acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA021123
- Marketing category
- NDA
- Marketing start
- 2001-08-15
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| tramadol hydrochloride | ACTIVE INGREDIENT | 9N7R477WCK | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| acetaminophen | ACTIVE MOIETY | 362O9ITL9D | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| tramadol | ACTIVE MOIETY | 39J1LGJ30J | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| powdered cellulose | INACTIVE INGREDIENT | SMD1X3XO9M | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-650-10 | 50458065010 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK | 10 blister pack | 2001-08-15 | 0000-00-00 | No | No | Current |
| 50458-650-60 | 50458065060 | 100 TABLET, COATED in 1 BOTTLE (50458-650-60) | | 2001-08-15 | 2022-10-26 | No | No | Current |