Prescription drug · ANDA
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release NDC 63629-2304
hydrocodone polistirex and chlorpheniramine polistirex · Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL · Suspension, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2304-1 | 63629230401 | 473 mL in 1 BOTTLE, UNIT-DOSE (63629-2304-1)Marketed from Mar 6, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releaseSuffix: extended-release
- Generic name (nonproprietary)
- hydrocodone polistirex and chlorpheniramine polistirex
- Active ingredients
- Hydrocodone bitartrate — 10 mg/5mLChlorpheniramine maleate — 8 mg/5mL
- Dosage form
- Suspension, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091632
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-2304_06d725a6-f0b9-499e-a95b-b2cee637ca59SPL ID 06d725a6-f0b9-499e-a95b-b2cee637ca59SPL set ID eecaa52b-f636-4ae4-a60f-d5e2503ab53bRxCUI 1087459UNII NO70W886KK, V1Q0O9OJ9Z
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463629230401followed by a unit qualifier and the quantityPackage 63629-2304-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use : • Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4 ) ]. • Contraindicated in pediatric patients less than 6 years of age [ see Contraindications (4) ]. • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients f…
Excerpt only. Read the full label for complete information.
About NDC 63629-2304
- What is NDC 63629-2304?
- 63629-2304 is the product NDC for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release, Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL suspension, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release (Hydrocodone Polistirex and Chlorpheniramine Polistirex).
- What is the active ingredient?
- Hydrocodone bitartrate, Chlorpheniramine maleate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release?
- 2 other product NDCs are listed under this name. See all Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releasehydrocodone polistirex and chlorpheniramine polistirex | Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL | Suspension, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-086 | 27808-0086-0127808-0086-02 |
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releasehydrocodone polistirex and chlorpheniramine polistirex | Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL | Suspension, Extended releaseOral | Bryant Ranch Prepack | 63629-2303 | 63629-2303-01 |
Other NDCs under ANDA 091632
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releasehydrocodone polistirex and chlorpheniramine polistirex | Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL | Suspension, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-086 |
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-releasehydrocodone polistirex and chlorpheniramine polistirex | Hydrocodone bitartrate 10 mg/5mL; Chlorpheniramine maleate 8 mg/5mL | Suspension, Extended releaseOral | Bryant Ranch Prepack | 63629-2303 |