Over-the-counter drug · ANDA
Naproxen Sodium and Diphenhydramine HCL NDC 11673-819
Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 · Tablet · Oral · TARGET CORPORATION
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11673-819-08 | 1167308190811673081908 | 80 TABLET in 1 BOTTLE (11673-819-08)Marketed from Mar 1, 2024 |
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 and Diphenhydramine HCL
- Generic name (nonproprietary)
- naproxen sodium and diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Naproxen sodium — 220 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TARGET CORPORATIONNDC labeler code 11673
- 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 11673-819_46536f85-5a10-9ebe-e063-6394a90a97bdSPL ID 46536f85-5a10-9ebe-e063-6394a90a97bdSPL set ID fe82699d-fdc2-038e-e053-6294a90a606cRxCUI 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
N411673081908followed by a unit qualifier and the quantityPackage 11673-0819-08. 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 11673-819
- What is NDC 11673-819?
- 11673-819 is the product NDC for Naproxen Sodium and Diphenhydramine HCL, Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 tablet, listed with the FDA by TARGET CORPORATION. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium and Diphenhydramine HCL.
- What is the active ingredient?
- Diphenhydramine hydrochloride, Naproxen sodium.
- Who is the labeler?
- TARGET CORPORATION, NDC labeler code 11673. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen Sodium and Diphenhydramine HCL?
- 2 other product NDCs are listed under this name. See all Naproxen Sodium and Diphenhydramine HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen Sodium and Diphenhydramine HCL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen Sodium and Diphenhydramine HCl | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-814 | 62207-0814-3862207-0814-3962207-0814-47+1 more |
| Naproxen Sodium and Diphenhydramine HClnaproxen sodium and diphenhydramine | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1422 | 69238-1422-0269238-1422-0469238-1422-06+1 more |
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 | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-814 |
| Naproxen Sodium Diphenhydramine HCl | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC | 69842-328 |
| Naproxen Sodium Diphenhydramine HCL | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Walmart | 79903-204 |
| Naproxen Sodium Diphenhydramine Hydrochloride | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | SAFEWAY | 21130-814 |