NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3822Add 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
70518-3822-07051838220030 TABLET in 1 BLISTER PACK (70518-3822-0)Marketed from Aug 6, 2023
70518-3822-17051838220160 TABLET in 1 BOTTLE, PLASTIC (70518-3822-1)Marketed from Aug 23, 2023
70518-3822-27051838220220 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2)Marketed from Aug 23, 2023
70518-3822-37051838220330 TABLET in 1 BOTTLE, PLASTIC (70518-3822-3)Marketed from Aug 24, 2023
70518-3822-47051838220414 TABLET in 1 BOTTLE, PLASTIC (70518-3822-4)Marketed from Aug 24, 2023
70518-3822-5705183822056 TABLET in 1 BLISTER PACK (70518-3822-5)Marketed from Sep 9, 2023
70518-3822-77051838220712 TABLET in 1 BOTTLE, PLASTIC (70518-3822-7)Marketed from Feb 23, 2024

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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
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 70518-3822_53c283c3-2de7-cd02-e063-6394a90ab181SPL ID 53c283c3-2de7-cd02-e063-6394a90ab181SPL set ID ccd95dfc-9236-4707-a715-6a12c91519ffRxCUI 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

N470518382200 followed by a unit qualifier and the quantity

Package 70518-3822-00. 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 70518-3822

What is NDC 70518-3822?
70518-3822 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 7 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?
REMEDYREPACK INC., NDC labeler code 70518. 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?
184 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 185 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 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
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-0784
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2396

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