NDC codes

FDA NDC Directory
Product NDC (as listed)70954-928Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0928Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70954-928-1070954092810100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10)Marketed from Jun 13, 2024

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 — 500 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218497
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70954-928_5c522cd1-1631-4254-ae44-cef65573b29fSPL ID 5c522cd1-1631-4254-ae44-cef65573b29fSPL set ID 052e6fe3-d619-42c3-b64e-67c7aaf7271cRxCUI 311915, 603103UNII 57Y76R9ATQUPC 0370954925101, 0370954928102

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

N470954092810 followed by a unit qualifier and the quantity

Package 70954-0928-10. 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 delayed-release tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis Naproxen delayed-release tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-928

What is NDC 70954-928?
70954-928 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, delayed release, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?
185 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NaproxenNaproxen 500 mg/1TabletOralREMEDYREPACK INC.70518-475070518-4750-00
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-078467046-0784-03
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-049967046-0499-03
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-050067046-0500-03
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-050167046-0501-03
NaproxenNaproxen 375 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21111534-0211-01
NaproxenNaproxen 500 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21211534-0212-01
NaproxenNaproxen 250 mg/1TabletOralREMEDYREPACK INC.70518-451470518-4514-00
NaproxenNaproxen 500 mg/1TabletOralMedcore LLC82461-71182461-0711-60
NaproxenNaproxen 125 mg/5mLSuspensionOralAurobindo Pharma Limited59651-52859651-0528-47

All 186 Naproxen NDCs

Other NDCs under ANDA 218497

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218497
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 375 mg/1Tablet, Delayed releaseOralANI Pharmaceuticals, Inc.70954-925

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