Tussionex Pennkinetic
- Product NDC
- 53014-548
- 11-digit product format
- 530140548
- Labeler code
- 53014
- Product ID
- 53014-548_0503c2c1-238b-4189-9b9c-08e712fa9313
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone polistirex and chlorpheniramine polistirex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Unither Manufacturing LLC
- Application
- NDA019111
- Marketing category
- NDA
- Marketing start
- 1987-12-31
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE; CHLORPHENIRAMINE
- Active strength
- 10 mg/5mL; mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53014-548-01 | Tussionex Pennkinetic | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 7 |
| 53014-548-01 | Tussionex Pennkinetic | 115 mL in 1 BOTTLE, PLASTIC | SUSPENSION, EXTENDED RELEASE | 115 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| chlorpheniramine | ACTIVE INGREDIENT | 3U6IO1965U | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| hydrocodone | ACTIVE INGREDIENT | 6YKS4Y3WQ7 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| chlorpheniramine | ACTIVE MOIETY | 3U6IO1965U | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| hydrocodone | ACTIVE MOIETY | 6YKS4Y3WQ7 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| ascorbic acid | INACTIVE INGREDIENT | PQ6CK8PD0R | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| high fructose corn syrup | INACTIVE INGREDIENT | XY6UN3QB6S | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| polyethylene glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53014-548 | TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING LLC] | 7 | Legacy NDC, 2 package rows | 20170330_af2caf33-e587-4d80-9523-44e1b565aae2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53014-548-01 | 53014054801 | 1 in 1 CARTON | Historical |