Prescription drug · ANDA
Promethazine Hydrochloride and Codeine Phosphate NDC 27808-065
Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL · Solution · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-065-02 | 2780800650227808006502 | 473 mL in 1 BOTTLE, PLASTIC (27808-065-02)Marketed from Mar 12, 2018 |
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 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
- Labeler
- Cranbury Pharmaceuticals, LLCNDC labeler code 27808
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200386
- Marketing start
- Marketing end
- DEA schedule
- CV
- Other FDA classes
- Full Opioid Agonists (Mechanism)Phenothiazines (Chemical structure)
- Identifiers
- Product ID 27808-065_981526cb-82c9-4a44-a891-7c44c708163eSPL ID 981526cb-82c9-4a44-a891-7c44c708163eSPL set ID 785c605e-1907-4fac-8b69-d504a2076f8eRxCUI 991486UNII R61ZEH7I1I, GSL05Y1MN6UPC 0327808065025
- 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
N427808006502followed by a unit qualifier and the quantityPackage 27808-0065-02. 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.
About NDC 27808-065
- What is NDC 27808-065?
- 27808-065 is the product NDC for Promethazine Hydrochloride and Codeine Phosphate, Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL solution, listed with the FDA by Cranbury Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Promethazine Hydrochloride and Codeine Phosphate.
- What is the active ingredient?
- Promethazine hydrochloride, Codeine phosphate.
- Who is the labeler?
- Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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 Codeine Phosphate?
- 4 other product NDCs are listed under this name. See all Promethazine Hydrochloride and Codeine Phosphate 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 Codeine Phosphate 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 Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Cosette Pharmaceuticals, Inc. | 0713-0823 | 00713-0823-75 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-139 | 70752-0139-0670752-0139-12 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0065 | 17856-0065-0117856-0065-02 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2042 | 72162-2042-02 |
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 | Cosette Pharmaceuticals, Inc. | 0713-0823 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0065 |
| Promethazine Hydrochloride and Codeine Phosphate | Promethazine hydrochloride 6.25 mg/5mL; Codeine phosphate 10 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2042 |