Over-the-counter drug · ANDA
equaline naproxen sodium pm NDC 41163-593
diphenhydramine hydrochloride, naproxen sodium · Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-593-71 | 4116305937141163059371 | 1 BOTTLE in 1 CARTON (41163-593-71) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 25, 2022 |
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)
- equaline naproxen sodium pm
- Generic name (nonproprietary)
- diphenhydramine hydrochloride, naproxen sodium
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208499
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41163-593_26bb9c64-c1af-409a-852e-3b2084de8b6aSPL ID 26bb9c64-c1af-409a-852e-3b2084de8b6aSPL set ID ed7bfa3f-4972-4ab6-9f0c-0873a11571a9RxCUI 1550957UNII TC2D6JAD40, 9TN87S3A3C
- 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
N441163059371followed by a unit qualifier and the quantityPackage 41163-0593-71. 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.
About NDC 41163-593
- What is NDC 41163-593?
- 41163-593 is the product NDC for equaline naproxen sodium pm, Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- equaline naproxen sodium pm (Diphenhydramine hydrochloride, naproxen sodium).
- What is the active ingredient?
- Diphenhydramine hydrochloride, Naproxen sodium.
- Who is the labeler?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for equaline naproxen sodium pm?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 208499
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 |
|---|---|---|---|---|
| All Night Pain Relief PMdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-2264 |
| basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-310 |
| careone naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-264 |
| dg health naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-858 |
| good sense naproxen sodiumdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-8264 |
| Naproxen Sodium PMdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-639 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Kroger Company | 30142-753 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | H E B | 37808-264 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-526 |
| topcare all night pain relief pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-264 |
| up and up naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-687 |