Promethazine Hydrochloride NDC 0116-4023

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4023Add 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
0116-4023-16	00116402316	473 mL in 1 BOTTLE, PLASTIC (0116-4023-16)Marketed from Apr 7, 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
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 6.25 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Xttrium Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087953
Marketing start: Apr 7, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 0116-4023_302bfe23-7984-140e-e063-6394a90acad1SPL ID 302bfe23-7984-140e-e063-6394a90acad1SPL set ID 302bfea2-d403-d315-e063-6294a90a37ddRxCUI 992432UNII R61ZEH7I1IUPC 0301164023165
Pharmacologic class: 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

N400116402316 followed by a unit qualifier and the quantity

Package 00116-4023-16. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 087953

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

FDA NDC Directory listings under ANDA 087953
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Atlantic Biologicals Corp.	17856-4023