Over-the-counter drug · ANDA
Naproxen Sodium Diphenhydramine HCl NDC 69842-328
Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69842-328-02 | 69842032802 | 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)Marketed from May 14, 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)
- Naproxen Sodium Diphenhydramine HCl
- Generic name (nonproprietary)
- naproxen sodium diphenhydramine hcl
- Active ingredients
- Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- CVS PHARMACY, INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213663
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69842-328_46540a23-aad6-6637-e063-6394a90a569eSPL ID 46540a23-aad6-6637-e063-6394a90a569eSPL set ID bdac694e-ab2a-376d-e053-2a95a90a9467RxCUI 1550957UNII 9TN87S3A3C, TC2D6JAD40
- 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
N469842032802followed by a unit qualifier and the quantityPackage 69842-0328-02. 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 .
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.
Other NDCs under ANDA 213663
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 |
|---|---|---|---|---|
| Naproxen Sodium and Diphenhydramine HCL | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | TARGET CORPORATION | 11673-819 |
| Naproxen Sodium and Diphenhydramine HCl | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-814 |
| Naproxen Sodium Diphenhydramine Hydrochloride | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | SAFEWAY | 21130-814 |
| Naproxen Sodium Diphenhydramine HCL | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Walmart | 79903-204 |