Over-the-counter drug · ANDA
Naproxen Sodium 220mg NDC 69168-395
Naproxen sodium 220 mg/1 · Tablet, Coated · Oral · Allegiant Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-395-07 | 6916803950769168039507 | 10 TABLET, COATED in 1 BOTTLE (69168-395-07)Marketed from May 4, 2011 | |
| 69168-395-17 | 6916803951769168039517 | 300 TABLET, COATED in 1 BOTTLE (69168-395-17)Marketed from Apr 21, 2021 | |
| 69168-395-50 | 6916803955069168039550 | 50 TABLET, COATED in 1 BOTTLE (69168-395-50)Marketed from May 18, 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)
- Naproxen Sodium 220mg
- Generic name (nonproprietary)
- naproxen sodium 220mg
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090545
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69168-395_08dc5597-5820-47c7-aec4-72336b5b7089SPL ID 08dc5597-5820-47c7-aec4-72336b5b7089SPL set ID 14554f05-14e1-4c52-99ce-94561c42c0daRxCUI 849574UNII 9TN87S3A3C
- Pharmacologic class
- 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
N469168039507followed by a unit qualifier and the quantityPackage 69168-0395-07. 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)
Use(s) temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 69168-395
- What is NDC 69168-395?
- 69168-395 is the product NDC for Naproxen Sodium 220mg, Naproxen sodium 220 mg/1 tablet, coated, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium 220mg.
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. 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 220mg?
- 3 other product NDCs are listed under this name. See all Naproxen Sodium 220mg 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 220mg 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 220mg | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Grocery Outlet | 85828-394 | 85828-0394-92 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Athlete's Needs, Inc. | 53185-394 | 53185-0394-50 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Command Brands, LLC | 69197-394 | 69197-0394-24 |
Other NDCs under ANDA 090545
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 220mg | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Grocery Outlet | 85828-394 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-6099 |
| Naproxen Sodiumnaproxen sodium, coated tablets | Naproxen sodium 220 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-141 |
| Naproxen Sodiumnaproxen sodium tablet, coated | Naproxen sodium 220 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-144 |
| Calmadol Pain Relievernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | GRANDALL DISTRIBUTING, LLC | 48201-007 |
| Naproxen Caplets All day relief for painnaproxen sodium 220 mg | Naproxen sodium 220 mg/1 | TabletOral | Allegiant Health | 69168-362 |
| Flanax Pain Reliever/Fever Reducernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Navajo Manufacturing Company Inc. | 67751-125 |
| Naproxen Capletsnaproxen sodium 220 mg | Naproxen sodium 220 mg/1 | TabletOral | Allegiant Health | 69168-394 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Kroger Company | 41226-609 |
| Flanax Pain Reliever/Fever reducernaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Belmora LLC | 27854-505 |
| Belmora Flanaxnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Belmora LLC | 27854-555 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Walmart Inc. | 79903-389 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Command Brands, LLC | 69197-394 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-608 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-609 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-9608 |
| Back And Muscle Painnaproxen | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-9609 |
| Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-608 |
| All Day Back and Muscle Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Walmart Inc. | 79903-609 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Athlete's Needs, Inc. | 53185-394 |
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