Prescription drug · ANDA
Naproxen NDC 70010-137
Naproxen 250 mg/1 · Tablet · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-137-01 | 7001001370170010013701 | 100 TABLET in 1 BOTTLE (70010-137-01)Marketed from Apr 15, 2021 | |
| 70010-137-05 | 7001001370570010013705 | 500 TABLET in 1 BOTTLE (70010-137-05)Marketed from Apr 15, 2021 | |
| 70010-137-10 | 7001001371070010013710 | 1000 TABLET in 1 BOTTLE (70010-137-10)Marketed from Apr 15, 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
- Generic name (nonproprietary)
- naproxen
- Active ingredients
- Naproxen — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074140
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70010-137_5d4ecf88-60b8-9b8d-e063-6394a90aea1eSPL ID 5d4ecf88-60b8-9b8d-e063-6394a90aea1e
- 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
N470010013701followed by a unit qualifier and the quantityPackage 70010-0137-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70010-137
- What is NDC 70010-137?
- 70010-137 is the product NDC for Naproxen, Naproxen 250 mg/1 tablet, listed with the FDA by Granules Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen.
- What is the active ingredient?
- Naproxen.
- Who is the labeler?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. 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?
- 189 other product NDCs are listed under this name. See all Naproxen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen 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 | Naproxen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-092 | 87441-0092-01 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-190 | 60760-0190-60 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4750 | 70518-4750-00 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0784 | 67046-0784-03 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 | 67046-0499-03 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 | 67046-0500-03 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 | 67046-0501-03 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 | 11534-0211-01 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 | 11534-0212-01 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 | 70518-4514-00 |
Other NDCs under ANDA 074140
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 | Naproxen 375 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-030 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4439 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-457 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-138 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-139 |
| Naproxennaproxen sodium | Naproxen sodium 250 mg/1 | TabletOral | Granules India Ltd | 62207-745 |
| Naproxennaproxen sodium | Naproxen sodium 375 mg/1 | TabletOral | Granules India Ltd | 62207-746 |
| Naproxennaproxen sodium | Naproxen sodium 500 mg/1 | TabletOral | Granules India Ltd | 62207-747 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Redpharm Drug | 67296-2235 |