Over-the-counter drug · ANDA
Naproxen Sodium PM (Naproxen sodium) NDC 70677-0064
Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-0064-1 | 7067700640170677006401 | 1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) / 20 TABLET in 1 BOTTLE, PLASTICMarketed from Dec 31, 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 PM
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strategic Sourcing Services LLCNDC labeler code 70677
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209726
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70677-0064_eb781b4d-79e1-48e2-b903-57b82e006befSPL ID eb781b4d-79e1-48e2-b903-57b82e006befSPL set ID 03a331d8-c957-4949-894f-51d9bd15e0d0RxCUI 1550957UNII 9TN87S3A3C, TC2D6JAD40UPC 0010939921444
- 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
N470677006401followed by a unit qualifier and the quantityPackage 70677-0064-01. 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 help you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
About NDC 70677-0064
- What is NDC 70677-0064?
- 70677-0064 is the product NDC for Naproxen Sodium PM (naproxen sodium), Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Strategic Sourcing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium PM (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium, Diphenhydramine hydrochloride.
- Who is the labeler?
- Strategic Sourcing Services LLC, NDC labeler code 70677. 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 PM?
- 4 other product NDCs are listed under this name. See all Naproxen Sodium PM 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 PM 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 PMdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-639 | 21130-0639-71 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | H E B | 37808-264 | 37808-0264-2737808-0264-60 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-526 | 41250-0526-27 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Kroger Company | 30142-753 | 30142-0753-27 |
Other NDCs under ANDA 209726
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 HClnaproxen sodium and diphenhydramine | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1422 |