What is NDC 0116-4023?

0116-4023 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 6.25 mg/5mL syrup, listed with the FDA by Xttrium Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Xttrium Laboratories, Inc., NDC labeler code 0116. 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?

116 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	0011640231600116402316	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.NDC labeler code 0116
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

Current FDA label (SPL), effective Apr 7, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operativ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0116-4023

What is NDC 0116-4023?: 0116-4023 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 6.25 mg/5mL syrup, listed with the FDA by Xttrium Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Promethazine Hydrochloride.
What is the active ingredient?: Promethazine hydrochloride.
Who is the labeler?: Xttrium Laboratories, Inc., NDC labeler code 0116. 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?: 116 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Promethazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-115	82868-0115-20
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1043	67046-1043-03
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-070	87441-0070-01
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1854	00121-1854-16
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4419	70518-4419-00
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Atlantic Biologicals Corp.	17856-4023	17856-4023-01
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447	67046-1447-03
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-016	81033-0016-50
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3373	55154-3373-00
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Bryant Ranch Prepack	72162-2377	72162-2377-02

All 117 Promethazine Hydrochloride NDCs

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