NDC 27808-057

NDC codes

FDA NDC Directory

Product NDC (as listed)27808-057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width27808-0057Add 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
27808-057-01	27808005701	473 mL in 1 BOTTLE, PLASTIC (27808-057-01)Marketed from Nov 15, 2021

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 Dextromethorphan Hydrobromide
Generic name (nonproprietary): promethazine hydrochloride and dextromethorphan hydrobromide
Active ingredients: Promethazine hydrochloride — 6.25 mg/5mLDextromethorphan hydrobromide — 15 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Cranbury Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091687
Marketing start: Jan 31, 2014
Marketing end: Apr 1, 2027
Other FDA classes: Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32SPL ID c48beb7d-69be-4ace-82b1-d1a1210b7f32SPL set ID a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3RxCUI 991528UNII R61ZEH7I1I, 9D2RTI9KYHUPC 0327808057013
Pharmacologic class: Phenothiazine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N427808005701 followed by a unit qualifier and the quantity

Package 27808-0057-01. 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 Dec 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091687

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091687
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL	SolutionOral	A-S Medication Solutions	50090-6755
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL	SolutionOral	Cosette Pharmaceuticals, Inc.	0713-0780
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL	SolutionOral	Bryant Ranch Prepack	72162-2039

Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDC 27808-057