Over-the-counter drug · ANDA
Naproxen Sodium NDC 68196-255
Naproxen sodium 220 mg/1 · Tablet, Coated · Oral · SAM'S WEST INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-255-20 | 6819602552068196025520 | 400 TABLET, COATED in 1 BOTTLE (68196-255-20)Marketed from Mar 1, 2023 | |
| 68196-255-40 | 6819602554068196025540 | 400 TABLET, COATED in 1 BOTTLE (68196-255-40)Marketed from May 1, 2025 |
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, Coated
- Route
- Oral
- Labeler
- SAM'S WEST INCNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075168
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68196-255_8f4b0483-1a09-88f8-d289-faed40edd37cSPL ID 8f4b0483-1a09-88f8-d289-faed40edd37cSPL set ID 7a87a339-4482-ec9e-3c77-7ccb9cea2c4cRxCUI 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
N468196025520followed by a unit qualifier and the quantityPackage 68196-0255-20. 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.
About NDC 68196-255
- What is NDC 68196-255?
- 68196-255 is the product NDC for Naproxen Sodium, Naproxen sodium 220 mg/1 tablet, coated, listed with the FDA by SAM'S WEST INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium.
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- SAM'S WEST INC, NDC labeler code 68196. 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?
- 144 other product NDCs are listed under this name. See all Naproxen Sodium 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 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 | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-988 | 72288-0988-75 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-244 | 57344-0244-03 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0574 | 80425-0574-0180425-0574-0280425-0574-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-245 | 42507-0245-0142507-0245-0842507-0245-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-844 | 42507-0844-0142507-0844-14 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Capsule, Liquid filledOral | TARGET Corporation | 11673-651 | 11673-0651-78 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-593 | 21130-0593-79 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0531 | 80425-0531-0180425-0531-0280425-0531-03 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0532 | 80425-0532-0180425-0532-0280425-0532-03 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-108 | 83324-0108-0183324-0108-2483324-0108-50 |
Other NDCs under ANDA 075168
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 | Kroger Company | 30142-954 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Limited | 55111-272 |
| Naproxen Sodium Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-073 |
| Naproxen Sodium Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-074 |
| Naproxen Sodium Back and Muscle Pain Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-060 |
| Naproxen Sodium Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr Reddy's Laboratories Inc | 43598-058 |
| Naproxen Sodium Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-071 |
| Naproxen Sodium Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-072 |
| Naproxen Sodium Headache Pain Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Dr.Reddy's Laboratories Inc | 43598-059 |