Prescription drug · NDA AUTHORIZED GENERIC
Naproxen Sodium NDC 47781-153
Naproxen sodium 375 mg/1 · Tablet, Film coated, Extended release · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-153-01 | 4778101530147781015301 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01)Marketed from Mar 11, 2015 |
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 — 375 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Alvogen Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020353
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 47781-153_6a207289-a8f0-9db1-548f-b55af6131677SPL ID 6a207289-a8f0-9db1-548f-b55af6131677SPL set ID 9225acaa-209f-958b-2c51-9a46995dec33RxCUI 1116320, 1116339, 1116349UNII 9TN87S3A3CUPC 0347781153014, 0347781155308, 0347781154752
- 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
N447781015301followed by a unit qualifier and the quantityPackage 47781-0153-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [ see Warnings and Precautions ( 5 ) ]. Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 47781-153
- What is NDC 47781-153?
- 47781-153 is the product NDC for Naproxen Sodium, Naproxen sodium 375 mg/1 tablet, film coated, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, 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?
- Alvogen Inc., NDC labeler code 47781. 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 NDA 020353
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 |
|---|---|---|---|---|
| Naprelannaproxen sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-249 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-250 |
| Naprelannaproxen sodium | Naproxen sodium 750 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-251 |
| Naprelannaproxen sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Almatica Pharma LLC | 52427-272 |
| Naprelannaproxen sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Almatica Pharma LLC | 52427-273 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-252 |
| Naproxen Sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-253 |
| Naproxen Sodium | Naproxen sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Alvogen Inc. | 47781-154 |
| Naproxen Sodium | Naproxen sodium 375 mg/1 | Tablet, Film coated, Extended releaseOral | SA3, LLC | 69420-1375 |