Prescription drug · ANDA
Promethazine Hydrochloride and Phenylephrine Hydrochloride (Promethazine and phenylephrine) NDC 65162-679
Promethazine hydrochloride 6.25 mg/5mL; Phenylephrine hydrochloride 5 mg/5mL · Solution · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-679-86 | 6516206798665162067986 | 118 mL in 1 BOTTLE (65162-679-86)Marketed from Aug 25, 2009 | |
| 65162-679-90 | 6516206799065162067990 | 473 mL in 1 BOTTLE (65162-679-90)Marketed from Aug 25, 2009 |
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 and phenylephrine
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mLPhenylephrine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040902
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Phenothiazines (Chemical structure)
- Identifiers
- Product ID 65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334aSPL ID 1cd384c6-b844-40d6-84bf-cdea9bbd334aSPL set ID cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4RxCUI 1248057UNII R61ZEH7I1I, 04JA59TNSJUPC 0365162679861, 0365162679908
- 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
N465162067986followed by a unit qualifier and the quantityPackage 65162-0679-86. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
About NDC 65162-679
- What is NDC 65162-679?
- 65162-679 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 Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Promethazine Hydrochloride and Phenylephrine Hydrochloride (Promethazine and Phenylephrine).
- What is the active ingredient?
- Promethazine hydrochloride, Phenylephrine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL; Phenylephrine hydrochloride 5 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-345 | 64950-0345-16 |