Naproxen Sodium Pm Tablet
NDC Package 62011-0396-1
Package Information
Naproxen Sodium Pm (naproxen sodium) tablets is naproxen is used to relieve pain from various conditions. This formulation utilizes a tablet delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 62011-0396 and is authorized under FDA application ANDA209726.
Identification & Billing
- RxCUI: 1550957 - diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral Tablet
- RxCUI: 1550957 - diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet
Clinical Specifications
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 62011 - Strategic Sourcing Services Llc
- 62011-0396 - Naproxen Sodium Pm
- 62011-0396-1 - 1 BOTTLE, PLASTIC in 1 BOX / 20 TABLET in 1 BOTTLE, PLASTIC
- 62011-0396 - Naproxen Sodium Pm
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 62011-0396-1 identifies a specific commercial package of 1 bottle, plastic in 1 box / 20 tablet in 1 bottle, plastic of Naproxen Sodium Pm, a human over the counter drug labeled by Strategic Sourcing Services Llc. This tablet is formulated for oral use and contains diphenhydramine hydrochloride; naproxen sodium as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Strategic Sourcing Services Llc on January 31, 2019.
What are the primary indications for this medication?
Naproxen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.
How is this Strategic Sourcing Services Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 62011039601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.