Over-the-counter drug · ANDA
Naproxen Sodium NDC 49483-609
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-609-00 | 49483060900 | 6500 TABLET, FILM COATED in 1 BAG (49483-609-00)Marketed from Mar 28, 2016 | |
| 49483-609-01 | 49483060901 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-609-01)Marketed from Mar 28, 2016 | |
| 49483-609-05 | 49483060905 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-609-05)Marketed from Mar 28, 2016 |
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
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC
- 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 49483-609_cbf198fe-25e4-694c-e053-2995a90aae22SPL ID cbf198fe-25e4-694c-e053-2995a90aae22SPL set ID 17ecaee0-c1c6-4360-81c1-d6afe50b9b27RxCUI 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
N449483060900followed by a unit qualifier and the quantityPackage 49483-0609-00. 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 temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Flanax Pain Reliever/Fever Reducernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Navajo Manufacturing Company Inc. | 67751-125 |
| Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-608 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-9608 |
| Naproxen Caplets All day relief for painnaproxen sodium 220 mg | Naproxen sodium 220 mg/1 | TabletOral | Allegiant Health | 69168-362 |
| Naproxen Capletsnaproxen sodium 220 mg | Naproxen sodium 220 mg/1 | TabletOral | Allegiant Health | 69168-394 |
| Back And Muscle Painnaproxen | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-9609 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Allegiant Health | 69168-395 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-690 |
| Calmadol Pain Relievernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | GRANDALL DISTRIBUTING, LLC | 48201-007 |
| Naproxen Sodiumnaproxen sodium tablet, coated | Naproxen sodium 220 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-144 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WALGREENS | 0363-6099 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Walmart Inc. | 79903-389 |
| Naproxen Sodiumnaproxen sodium, coated tablets | Naproxen sodium 220 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-141 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Command Brands, LLC | 69197-394 |
| 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, Film coatedOral | Grocery Outlet | 85828-394 |
| Naproxen Sodium 220mg | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Athlete's Needs, Inc. | 53185-394 |
| Naproxen Sodiumnaproxen sodium 220mg | Naproxen sodium 220 mg/1 | TabletOral | CVS Pharmacy, Inc. | 51316-608 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Kroger Company | 41226-609 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-608 |
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