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Promethazine and Phenylephrine HCl, and Codeine Phosphate

NDC 65162-694, Promethazine, Phenylephrine, Codeine, syrup, from Amneal Pharmaceuticals LLC.

Product NDC
65162-694
Status
Listed
Labeler
Amneal Pharmaceuticals LLC
Dosage form
SYRUP
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA200963
DEA schedule
CV
Request
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Product

Active ingredients and packages

Active ingredients

  • PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
  • CODEINE PHOSPHATE10 mg/5mL

Pharmacologic classes

Adrenergic alpha1-Agonists [MoA]; Full Opioid Agonists [MoA]; Opioid Agonist [EPC]; Phenothiazine [EPC]; Phenothiazines [CS]; alpha-1 Adrenergic Agonist [EPC]

Package NDCNDC-11Package
65162-694-8665162069486118 mL in 1 BOTTLE (65162-694-86)
65162-694-9065162069490473 mL in 1 BOTTLE (65162-694-90)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/5f23b254-872b-4e88-91be-710c3ea7687b

Use it

Look up 65162-694 from code or an agent

curl
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  -H "Authorization: Bearer $HDEV_API_KEY"
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.