Over-the-counter drug · ANDA
Naproxen Sodium HEADACHE PAIN (Naproxen sodium) NDC 58602-735
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-735-07 | 5860207350758602073507 | 1 BOTTLE in 1 CARTON (58602-735-07) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 | |
| 58602-735-19 | 5860207351958602073519 | 1 BOTTLE in 1 CARTON (58602-735-19) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 21, 2023 | |
| 58602-735-21 | 5860207352158602073521 | 1 BOTTLE in 1 CARTON (58602-735-21) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 | |
| 58602-735-29 | 5860207352958602073529 | 1 BOTTLE in 1 CARTON (58602-735-29) / 150 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 | |
| 58602-735-38 | 5860207353858602073538 | 1 BOTTLE in 1 CARTON (58602-735-38) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 | |
| 58602-735-40 | 5860207354058602073540 | 1 BOTTLE in 1 CARTON (58602-735-40) / 500 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 | |
| 58602-735-78 | 5860207357858602073578 | 1 BOTTLE in 1 CARTON (58602-735-78) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2021 |
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 HEADACHE PAIN
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205497
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-735_b14dd7e8-b43c-4d9e-9609-13d9f30a74c4SPL ID b14dd7e8-b43c-4d9e-9609-13d9f30a74c4SPL set ID e4a9ea0e-aec4-493c-b9b4-5e5a91d260d5RxCUI 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
N458602073507followed by a unit qualifier and the quantityPackage 58602-0735-07. 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)
Uses 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 58602-735
- What is NDC 58602-735?
- 58602-735 is the product NDC for Naproxen Sodium HEADACHE PAIN (naproxen sodium), Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by Aurohealth LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium HEADACHE PAIN (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. 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 HEADACHE PAIN?
- 3 other product NDCs are listed under this name. See all Naproxen Sodium HEADACHE PAIN 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 HEADACHE PAIN 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 Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-071 | 43598-0071-01 |
| Naproxen Sodium Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-072 | 43598-0072-01 |
| Naproxen Sodium HEADACHE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-737 | 58602-0737-0758602-0737-1258602-0737-19+8 more |
Other NDCs under ANDA 205497
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 | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-232 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-231 |
| Amazon Basic Care Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-366 |
| Naproxen Sodium HEADACHE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-737 |
| Naproxen Sodium BACK AND MUSCLE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-736 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-738 |
| Naproxen Sodium BACK AND MUSCLE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-739 |
| Flanax Pain Reliever/Fever Reducernaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-700 |
| Ana-Dent PAIN RELIEFnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-701 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-819 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-845 |