Over-the-counter drug · ANDA
Naproxen Sodium Diphenhydramine Hydrochloride NDC 21130-814
Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · SAFEWAY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-814-05 | 21130081405 | 50 TABLET in 1 BOTTLE (21130-814-05)Marketed from Jun 30, 2023 |
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 Hydrochloride
- Generic name (nonproprietary)
- naproxen sodium diphenhydramine hydrochloride
- Active ingredients
- Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SAFEWAY
- 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 21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8cSPL ID 463f13c5-0aeb-3fa5-e063-6394a90afe8cSPL set ID ed0f3275-f156-13a3-e053-2a95a90a2ce8RxCUI 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
N421130081405followed by a unit qualifier and the quantityPackage 21130-0814-05. 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 asscoiated 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 Diphenhydramine HCl | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC | 69842-328 |
| 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 HCL | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Walmart | 79903-204 |