Hydrocodone Polistirex and Chlorpheniramine Polistirex
- Product NDC
- 63629-2303
- 11-digit product format
- 636292303
- Labeler code
- 63629
- Product ID
- 63629-2303_44e02320-4dfa-4ebb-aa60-0bb4c094c103
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Polistirex and Chlorpheniramine Polistirex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091632
- Marketing category
- ANDA
- Marketing start
- 2015-03-06
- Substance
- CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
- Active strength
- 8; 10 mg/5mL; mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Polistirex and Chlorpheniramine Polistirex
- Brand name suffix
- extended-release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 8 mg/5mL |
| HYDROCODONE BITARTRATE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, NO70W886KK |
| Rxcui | 1087459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-2303-1 | Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 106 |
| 63629-2303-1 | Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release | 115 mL in 1 BOTTLE, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 115 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2303 | HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 2 package rows | 20250315_e0010aac-2d7e-4dd3-8024-ff0c7f668b77.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2303-1 | 63629230301 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (63629-2303-1) / 115 mL in 1 BOTTLE, UNIT-DOSE | 2015-03-06 | 0000-00-00 | No | No | Current |