Hydrocodone Polistirex and Chlorpheniramine Polisitrex
- Product NDC
- 17856-0235
- 11-digit product format
- 178560235
- Labeler code
- 17856
- Product ID
- 17856-0235_f75c6ba1-6695-4bcb-88ec-63efd2acdf92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Polistirex and Chlorpheniramine Polisitrex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA091632
- Marketing category
- ANDA
- Marketing start
- 2012-08-16
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE
- 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 |
|---|
| 17856-0235-1 | Hydrocodone Polistirex and Chlorpheniramine Polisitrex | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 5 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | INACTIVE INGREDIENT | 461P5CJN6T | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SODIUM POLYSTYRENE SULFONATE | INACTIVE INGREDIENT | 1699G8679Z | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| VINYL ACETATE | INACTIVE INGREDIENT | L9MK238N77 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0235 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS] | 2 | Legacy NDC, 1 package rows | 20150216_566d28f3-4b16-4881-9347-2175e5060ffb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 17856-0235-1 | 17856023501 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | Historical |