Prescription drug · ANDA

Naproxen NDC 43063-920

Naproxen 500 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)43063-920Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0920Add 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
43063-920-04430630920044 TABLET in 1 BOTTLE, PLASTIC (43063-920-04)Marketed from Dec 18, 2018
43063-920-06430630920066 TABLET in 1 BOTTLE, PLASTIC (43063-920-06)Marketed from May 31, 2019
43063-920-144306309201414 TABLET in 1 BOTTLE, PLASTIC (43063-920-14)Marketed from Feb 8, 2019
43063-920-154306309201515 TABLET in 1 BOTTLE, PLASTIC (43063-920-15)Marketed from Jan 16, 2019
43063-920-204306309202020 TABLET in 1 BOTTLE, PLASTIC (43063-920-20)Marketed from Feb 7, 2019
43063-920-284306309202828 TABLET in 1 BOTTLE, PLASTIC (43063-920-28)Marketed from Sep 24, 2019
43063-920-304306309203030 TABLET in 1 BOTTLE, PLASTIC (43063-920-30)Marketed from Jan 14, 2019
43063-920-604306309206060 TABLET in 1 BOTTLE, PLASTIC (43063-920-60)Marketed from Feb 18, 2019
43063-920-904306309209090 TABLET in 1 BOTTLE, PLASTIC (43063-920-90)Marketed from Sep 1, 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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091416
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 43063-920_415db902-541e-accc-e063-6394a90a54e5SPL ID 415db902-541e-accc-e063-6394a90a54e5SPL set ID a9f9ce81-9d51-4167-9581-974866a8fe31RxCUI 198014UNII 57Y76R9ATQUPC 0343063920305

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

N443063092004 followed by a unit qualifier and the quantity

Package 43063-0920-04. 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 .

Indications (excerpt from the label)

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED: FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS NAPROXEN TABLETS ARE ALSO INDICATED: FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS FOR RELIEF OF…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-920

What is NDC 43063-920?
43063-920 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 9 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 091416

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

FDA NDC Directory listings under ANDA 091416
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 250 mg/1TabletOralMARKSANS PHARMA LIMITED25000-138
NaproxenNaproxen 375 mg/1TabletOralMARKSANS PHARMA LIMITED25000-139
NaproxenNaproxen 500 mg/1TabletOralMARKSANS PHARMA LIMITED25000-140
NaproxenNaproxen 500 mg/1TabletOralQPharma Inc42708-140
NaproxenNaproxen 375 mg/1TabletOralTIME CAP LABORATORIES49483-617
NaproxenNaproxen 500 mg/1TabletOralTIME CAP LABORATORIES49483-618
NaproxenNaproxen 250 mg/1TabletOralTIME CAP LABORATORIES49483-619
NaproxenNaproxen 500 mg/1TabletOralNorthwind Health Company, LLC51655-621
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4006
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4381
NaproxenNaproxen 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4510
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack71335-0255
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack71335-0973
NaproxenNaproxen 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-436
NaproxenNaproxen 500 mg/1TabletOralDIRECT RX72189-136
NaproxenNaproxen 500 mg/1TabletOralAsclemed USA, Inc.76420-042
NaproxenNaproxen 375 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0048

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