Prescription drug · ANDA
Promethazine Hydrochloride and Phenylephrine Hydrochloride NDC 64950-345
Promethazine hydrochloride 6.25 mg/5mL; Phenylephrine hydrochloride 5 mg/5mL · Solution · Oral · Genus Lifesciences Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-345-16 | 6495003451664950034516 | 473 mL in 1 BOTTLE, PLASTIC (64950-345-16)Marketed from Jul 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Promethazine Hydrochloride and Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- promethazine hydrochloride and phenylephrine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mLPhenylephrine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Genus Lifesciences Inc.NDC labeler code 64950
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040654
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Phenothiazines (Chemical structure)
- Identifiers
- Product ID 64950-345_8c68bee7-b617-4573-a958-0476dc8a5b0fSPL ID 8c68bee7-b617-4573-a958-0476dc8a5b0f
- Pharmacologic class
- Phenothiazine; alpha-1 Adrenergic 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
N464950034516followed by a unit qualifier and the quantityPackage 64950-0345-16. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 64950-345
- What is NDC 64950-345?
- 64950-345 is the product NDC for Promethazine Hydrochloride and Phenylephrine Hydrochloride, Promethazine hydrochloride 6.25 mg/5mL; Phenylephrine hydrochloride 5 mg/5mL solution, listed with the FDA by Genus Lifesciences Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Promethazine Hydrochloride and Phenylephrine Hydrochloride.
- What is the active ingredient?
- Promethazine hydrochloride, Phenylephrine hydrochloride.
- Who is the labeler?
- Genus Lifesciences Inc., NDC labeler code 64950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Promethazine Hydrochloride and Phenylephrine Hydrochloride?
- 1 other product NDC are listed under this name. See all Promethazine Hydrochloride and Phenylephrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Promethazine Hydrochloride and Phenylephrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Promethazine Hydrochloride and Phenylephrine Hydrochloridepromethazine and phenylephrine | Promethazine hydrochloride 6.25 mg/5mL; Phenylephrine hydrochloride 5 mg/5mL | SolutionOral | Amneal Pharmaceuticals LLC | 65162-679 | 65162-0679-8665162-0679-90 |