Prescription drug · ANDA
Promethazine Hydrochloride and Codeine Phosphate NDC 0713-0823
Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL · Solution · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0823-75 | 00713082375 | 473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)Marketed from Dec 19, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Codeine Phosphate
- Generic name (nonproprietary)
- promethazine hydrochloride and codeine phosphate
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mLCodeine phosphate — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200386
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Full Opioid Agonists (Mechanism)Phenothiazines (Chemical structure)
- Identifiers
- Product ID 0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74cSPL ID ad6f539c-d968-4a3b-9550-ab7e78bee74cSPL set ID 3b02cda4-9b24-79c9-e063-6294a90af5b9RxCUI 991486UNII R61ZEH7I1I, GSL05Y1MN6UPC 0307130823753
- Pharmacologic class
- Opioid Agonist; Phenothiazine
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
N400713082375followed by a unit qualifier and the quantityPackage 00713-0823-75. 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)
Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs 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 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 addiction, abuse, and misuse with opioid…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200386
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 |
|---|---|---|---|---|
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Cranbury Pharmaceuticals, LLC | 27808-065 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2042 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0065 |