NDC codes

FDA NDC Directory
Product NDC (as listed)85534-0023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85534-0023Add 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
85534-0023-0855340023008553400230030 TABLET in 1 BOTTLE (85534-0023-0)Marketed from Jun 25, 2026
85534-0023-1855340023018553400230160 TABLET in 1 BOTTLE (85534-0023-1)Marketed from Jun 25, 2026
85534-0023-2855340023028553400230290 TABLET in 1 BOTTLE (85534-0023-2)Marketed from Jun 25, 2026
85534-0023-38553400230385534002303120 TABLET in 1 BOTTLE (85534-0023-3)Marketed from Jun 25, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 375 mg/1
Dosage form
Tablet
Route
Oral
Labeler
HAWAII REPACK, INC.NDC labeler code 85534
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212517
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 85534-0023_5524403b-dd49-46cf-e063-6294a90af278SPL ID 5524403b-dd49-46cf-e063-6294a90af278SPL set ID 888efc91-b4de-4691-b84c-fb871e7a6dfeRxCUI 198012, 198013, 198014UNII 57Y76R9ATQ

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

N485534002300 followed by a unit qualifier and the quantity

Package 85534-0023-00. 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 Tablets are 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 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 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 85534-0023

What is NDC 85534-0023?
85534-0023 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by HAWAII REPACK, INC.. It has 4 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?
HAWAII REPACK, INC., NDC labeler code 85534. 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.

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

Other Naproxen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NaproxenNaproxen 500 mg/1TabletOralUnit Dose Solutions, Inc.87441-09287441-0092-01
NaproxenNaproxen 500 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-19060760-0190-60
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

All 190 Naproxen NDCs

Other NDCs under ANDA 212517

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

FDA NDC Directory listings under ANDA 212517
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 375 mg/1TabletOralMedsource Pharmaceuticals45865-238
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5645
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5646
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5649
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-7676
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-8102
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-8103
NaproxenNaproxen 250 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-434
NaproxenNaproxen 375 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-435
NaproxenNaproxen 500 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-436
NaproxenNaproxen 375 mg/1TabletOralNorthwind Health Company, LLC51655-657
NaproxenNaproxen 500 mg/1TabletOralNorthwind Health Company, LLC51655-743
NaproxenNaproxen 500 mg/1TabletOralQuality Care Products, LLC55700-888
NaproxenNaproxen 500 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-564
NaproxenNaproxen 375 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-644
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack63629-8511
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack63629-8512
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack63629-8513
NaproxenNaproxen 500 mg/1TabletOralBryant Ranch Prepack63629-8514
NaproxenNaproxen 500 mg/1TabletOralBryant Ranch Prepack63629-8515

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