What is NDC 65162-694?

65162-694 is the product NDC for Promethazine and Phenylephrine HCl, and Codeine Phosphate, Promethazine hydrochloride 6.25 mg/5mL + 2 more ingredients syrup, 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 and Phenylephrine HCl, and Codeine Phosphate (Promethazine, Phenylephrine, Codeine).

What is the active ingredient?

Promethazine hydrochloride, Phenylephrine hydrochloride, Codeine phosphate.

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 and Phenylephrine HCl, and Codeine Phosphate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 65162-694

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-694Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0694Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65162-694-86	6516206948665162069486	118 mL in 1 BOTTLE (65162-694-86)Marketed from Nov 1, 2013
65162-694-90	6516206949065162069490	473 mL in 1 BOTTLE (65162-694-90)Marketed from Nov 1, 2013

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 and Phenylephrine HCl, and Codeine Phosphate
Generic name (nonproprietary): promethazine, phenylephrine, codeine
Active ingredients: Promethazine hydrochloride — 6.25 mg/5mLPhenylephrine hydrochloride — 5 mg/5mLCodeine phosphate — 10 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200963
Marketing start: Nov 1, 2013
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Full Opioid Agonists (Mechanism)Phenothiazines (Chemical structure)
Identifiers: Product ID 65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31SPL ID fa597180-cb04-48de-ba6c-1cc3781d7f31SPL set ID 5f23b254-872b-4e88-91be-710c3ea7687bRxCUI 996757UNII R61ZEH7I1I, 04JA59TNSJ, GSL05Y1MN6
Pharmacologic class: Opioid Agonist; 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

N465162069486 followed by a unit qualifier and the quantity

Package 65162-0694-86. 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 Jan 8, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] . Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) , Use in Specific Populations (8.4) ] . Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ] . Because of the risks of add…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-694

What is NDC 65162-694?: 65162-694 is the product NDC for Promethazine and Phenylephrine HCl, and Codeine Phosphate, Promethazine hydrochloride 6.25 mg/5mL + 2 more ingredients syrup, 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 and Phenylephrine HCl, and Codeine Phosphate (Promethazine, Phenylephrine, Codeine).
What is the active ingredient?: Promethazine hydrochloride, Phenylephrine hydrochloride, Codeine phosphate.
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 and Phenylephrine HCl, and Codeine Phosphate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Promethazine and Phenylephrine HCl, and Codeine Phosphate (Promethazine, phenylephrine, codeine) NDC 65162-694