Over-the-counter drug · ANDA
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever (Naproxen sodium) NDC 53746-192
Naproxen sodium 220 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-192-05 | 5374601920553746019205 | 500 TABLET in 1 BOTTLE (53746-192-05)Marketed from Nov 25, 2009 | |
| 53746-192-08 | 5374601920853746019208 | 8 TABLET in 1 VIAL (53746-192-08)Marketed from Nov 25, 2009 | |
| 53746-192-24 | 5374601922453746019224 | 24 TABLET in 1 BOTTLE (53746-192-24)Marketed from Nov 25, 2009 |
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 (NSAID) Fever Reducer/ Pain RelieverSuffix: Fever Reducer/ Pain Reliever
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079096
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53746-192_9cc39ab5-450a-4e0b-948d-fdebd66c0f6fSPL ID 9cc39ab5-450a-4e0b-948d-fdebd66c0f6fSPL set ID 0bb41b8c-6031-4e96-95e1-31adab811837RxCUI 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
N453746019205followed by a unit qualifier and the quantityPackage 53746-0192-05. 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)
INDICATION AND USAGE Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53746-192
- What is NDC 53746-192?
- 53746-192 is the product NDC for Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever, Naproxen sodium 220 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever (Naproxen Sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 (NSAID) Fever Reducer/ Pain Reliever?
- 1 other product NDC are listed under this name. See all Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever 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 (NSAID) Fever Reducer/ Pain Reliever 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 (NSAID) Fever Reducer/ Pain Relievernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-191 | 53746-0191-0553746-0191-0853746-0191-24 |
Other NDCs under ANDA 079096
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, CoatedOral | AAA Pharmaceutical, Inc. | 57344-145 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-244 |
| Medique Mediproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-237 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | H E B | 37808-068 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WinCo Foods, LLC | 67091-138 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | WinCo Foods, LLC | 67091-140 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-108 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-109 |
| Medique Mediproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2388 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-245 |
| All Day Pain Reliefnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-245 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-045 |
| CAREALL Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | New World Imports, Inc. | 51824-072 |
| Medique at Home Mediproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-737 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-465 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-466 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-144 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-145 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-444 |
| Naproxennaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-145 |
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