Naproxen Sodium and Diphenhydramine HCl NDC 69238-1422

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1422Add 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
69238-1422-2	69238142202	1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018
69238-1422-4	69238142204	1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018
69238-1422-6	69238142206	1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018
69238-1422-8	69238142208	1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Naproxen Sodium and Diphenhydramine HCl
Generic name (nonproprietary): naproxen sodium and diphenhydramine
Active ingredients: Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209726
Marketing start: Oct 23, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7SPL ID b9db3e35-7654-4bf3-8536-38f56b8780c7SPL set ID caca14cf-95f2-4c60-8bba-2154b8f353a3RxCUI 1550957UNII 9TN87S3A3C, TC2D6JAD40UPC 0369238142266
Pharmacologic class: Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N469238142202 followed by a unit qualifier and the quantity

Package 69238-1422-02. 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 Dec 30, 2023.

Indications (excerpt from the label)

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209726

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

FDA NDC Directory listings under ANDA 209726
Product	Strength	Form · route	Labeler	Product NDC
Naproxen Sodium PMnaproxen sodium	Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-0064