NDC codes

FDA NDC Directory
Product NDC (as listed)42192-619Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42192-0619Add 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
42192-619-1642192061916473 mL in 1 BOTTLE (42192-619-16)Marketed from Nov 12, 2020

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 — 125 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Acella Pharmaceuticals, LLCNDC labeler code 42192
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 018965
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 42192-619_47a98b71-a338-b13d-e063-6394a90a96f6SPL ID 47a98b71-a338-b13d-e063-6394a90a96f6SPL set ID 7e6f03fb-4b36-4418-9684-f45637abbb78RxCUI 311913UNII 57Y76R9ATQUPC 0342192619166

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

N442192061916 followed by a unit qualifier and the quantity

Package 42192-0619-16. 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 Suspension is indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen Suspension is a non-steroidal anti-inflammatory drug indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42192-619

What is NDC 42192-619?
42192-619 is the product NDC for Naproxen, Naproxen 125 mg/5mL suspension, listed with the FDA by Acella Pharmaceuticals, LLC. 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?
Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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

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